10 SHOOTER SAEED MULTI-BAND LIGATOR

Description of Event or Problem

DURING AN ENDOSCOPIC LIGATION PROCEDURE FOR INTERNAL HEMORRHOIDS, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PHYSICIAN INSTALLED THE DEVICE ONTO A FUJI ENDOSCOPE THEN ADVANCED INTO ESOPHAGUS, AFTER 3 BAND DEPLOYMENTS, THE PHYSICIAN FOUND THAT THE FOURTH BAND CANNOT BE RELEASED. USER RETRACTED THE ENDOSCOPE AND RE-INSTALLED THE DEVICE BUT STILL CANNOT RELEASE THE BAND, AND THE ENDOSCOPE BODY WAS TWISTED DUE TO TRIGGER CORD PULLING. USER CHANGED TO ANOTHER ONE OF THE SAME DEVICE TO LIGATE THE REST ESOPHAGEAL VARICES. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE 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: 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. THE BARREL AND BANDS DID NOT RETURN WITH THE DEVICE. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE, THE TRIGGER CORD WAS NO LONGER ATTACHED TO THE BARREL, HOWEVER, ONE OF THE BEADS ON THE TRIGGER CORD WAS MISSING AND NOT RETURNED; THIS MOST LIKELY OCCURRED DURING DIFFICULT DEPLOYMENT ATTEMPTS. A VISUAL EXAMINATION OF THE DEVICE WAS PERFORMED. THE TRIGGER CORD WAS EXAMINED AND NINETEEN OF THE TWENTY DEPLOYMENT BEADS WERE PRESENT; ONE BEAD WAS MISSING AND NOT RETURNED. THE BEAD MOST LIKELY CAME OFF DURING THE DIFFICULT DEPLOYMENT. THE BEADS WERE VERIFIED FOR CORRECT LOCATION. 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 124.2 CM BETWEEN THE KNOTS WHICH IS WITHIN 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 PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE, THE TRIGGER CORD WAS NO LONGER ATTACHED TO THE BARREL, HOWEVER, ONE OF THE BEADS ON THE TRIGGER CORD WAS MISSING AND NOT RETURNED; THIS MOST LIKELY OCCURRED DURING DIFFICULT DEPLOYMENT ATTEMPTS. 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. 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 10 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.