6 SHOOTER SAEED MULTI-BAND LIGATOR

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A WHITE PLASTIC BAG WITH AN OPEN BOX AND TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. ALL COMPONENTS RETURNED WITH THE DEVICE. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED, ALL 6 BANDS REMAINING ON THE BARREL DID NOT APPEAR TO BE MOVED OUT OF PLACE. A FUNCTIONAL TEST WAS PERFORMED ON THE 6 REMAINING BANDS ON THE BARREL. THE MULTI-BAND LIGATOR DEVICE WAS ATTACHED TO AN ENDOSCOPE THAT WAS PLACED IN A SIMULATED GASTROINTESTINAL POSITION WITH VACUUM ATTACHED. THE ENDOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 2.8 MM IN DIAMETER (OLYMPUS 2.8 GIF Q20 ENDOSCOPE). THE MULTI-BAND LIGATOR BARREL WAS ATTACHED ONTO THE END OF THE ENDOSCOPE. SIMULATED VARICES WERE PLACED AT THE END OF THE BARREL AND VACUUM PULLED AND THE REMAINING BANDS WERE FIRED. IT WAS OBSERVED THAT THE 6 REMAINING BANDS DEPLOYED AS INTENDED WITH NO DIFFICULTY IN DEPLOYMENT OBSERVED, BUT THEY DID NOT CONSTRICT AS EXPECTED. THIS IS DUE TO THE FUNCTIONAL TESTING BEING CONDUCTED AT ROOM TEMPERATURE INSTEAD OF AT BODY TEMPERATURE AS THE TEST WAS ONLY INTENDED TO TEST FOR SUCCESSFUL DEPLOYMENT. A VISUAL EXAMINATION OF THE DEVICE WAS PERFORMED. THE TRIGGER CORD WAS EXAMINED AND ALL TWELVE DEPLOYMENT BEADS WERE PRESENT. THE BEADS WERE VERIFIED FOR CORRECT LOCATION USING BEAD INSPECTION PLATE T2523. THE BEADS WERE EXAMINED USING MAGNIFICATION AND FOUND TO BE CORRECTLY FILLED AND HAD NO EVIDENCE OF EXCESS FLASH. THE TRIGGER CORD WAS INTACT AND NOT BROKEN. THE LENGTH OF THE TRIGGER CORD WAS MEASURED AT 143.7 CM BETWEEN THE KNOTS WHICH IS WITHIN THE 56" +2"/-1" (139.7-147.32 CM) TOLERANCE. AN EVALUATION OF THE HANDLE WHEEL MOVEMENT WAS PERFORMED AND THE WHEEL FUNCTIONED AS INTENDED. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORT. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS USED WITH AN OLYMPUS GASTROSCOPE. THE MBL-6-F IS DESIGNED TO WORK WITH FUJINON ENDOSCOPES. BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE ENDOSCOPE ACCESSORY CHANNEL IS COMPROMISED. IN THESE CASES, THE ENDOSCOPE ACCESSORY CHANNEL COLLAPSES, RESTRICTING THE TRIGGER CORD AND PREVENTING PROPER BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING STATEMENT: "USE OF AN ENDOSCOPE IN A SOUND STATE OF REPAIR IS A PREREQUISITE FOR A SUCCESSFUL MULTI-BAND LIGATION PROCEDURE." BAND DEPLOYMENT DIFFICULTY CAN ALSO OCCUR IF THE TRIGGER CORD IS NOT PROPERLY SEATED IN THE HANDLE ASSEMBLY. THE INSTRUCTIONS FOR USE ADVISE THE USER: "NOTE: KNOT MUST BE SEATED INTO HOLE OR HANDLE WILL NOT FUNCTION PROPERLY." A PRECAUTION IN THE INSTRUCTIONS FOR USE STATE: "IT IS VITAL THAT THE INTEGRITY OF THE WORKING CHANNEL IS INTACT AS GROOVES OR OTHER OBSTRUCTIONS IN THE WORKING CHANNEL CAN POTENTIALLY CAUSE THE STRING TO CATCH, RESULTING IN BAND DEPLOYMENT DIFFICULTY." IT IS POSSIBLE THAT THIS COULD LEAD TO BAND DEPLOYMENT DIFFICULTY AND DAMAGE TO THE TRIGGER CORD AS WELL. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS REGARDING THIS REPORT: THE INFORMATION PROVIDED BY THE USER INDICATES THAT THE DEVICE WAS USED WITH AN OLYMPUS ENDOSCOPE. THE MBL-6-F IS DESIGNED TO WORK WITH FUJINON ENDOSCOPES. A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

Description of Event or Problem

DURING AN ENDOSCOPIC LIGATION PROCEDURE FOR INTERNAL HEMORRHOIDS IN THE ANORECTAL REGION, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PATIENT WAS ALREADY IN POSITION, AND THE NURSE INSTALLED DEVICE NORMALLY. HOWEVER, THE FIRST ATTEMPT TO RELEASE [BANDS] WAS UNSUCCESSFUL AS THE PATIENT'S POSITION WAS ADJUSTED THE ANGLE. WHEN ATTEMPTING TO RELEASE IT AGAIN, THE DEVICE GOT STUCK. THE NURSE QUICKLY REPLACED IT WITH A NEW SET OF LIGATING DEVICES AND COMPLETED THE PROCEDURE. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS USED WITH AN OLYMPUS GASTROSCOPE. THE MBL-6-F IS DESIGNED TO WORK WITH FUJINON ENDOSCOPES. BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE ENDOSCOPE ACCESSORY CHANNEL IS COMPROMISED. IN THESE CASES, THE ENDOSCOPE ACCESSORY CHANNEL COLLAPSES, RESTRICTING THE TRIGGER CORD AND PREVENTING PROPER BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING STATEMENT: "USE OF AN ENDOSCOPE IN A SOUND STATE OF REPAIR IS A PREREQUISITE FOR A SUCCESSFUL MULTI-BAND LIGATION PROCEDURE." BAND DEPLOYMENT DIFFICULTY CAN ALSO OCCUR IF THE TRIGGER CORD IS NOT PROPERLY SEATED IN THE HANDLE ASSEMBLY. THE INSTRUCTIONS FOR USE ADVISE THE USER: "NOTE: KNOT MUST BE SEATED INTO HOLE OR HANDLE WILL NOT FUNCTION PROPERLY." A PRECAUTION IN THE INSTRUCTIONS FOR USE STATE: "IT IS VITAL THAT THE INTEGRITY OF THE WORKING CHANNEL IS INTACT AS GROOVES OR OTHER OBSTRUCTIONS IN THE WORKING CHANNEL CAN POTENTIALLY CAUSE THE STRING TO CATCH, RESULTING IN BAND DEPLOYMENT DIFFICULTY." IT IS POSSIBLE THAT THIS COULD LEAD TO BAND DEPLOYMENT DIFFICULTY AND DAMAGE TO THE TRIGGER CORD AS WELL. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS REGARDING THIS REPORT: THE INFORMATION PROVIDED BY THE USER INDICATES THAT THE DEVICE WAS USED WITH AN OLYMPUS ENDOSCOPE. THE MBL-6-F IS DESIGNED TO WORK WITH FUJINON ENDOSCOPES. A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.