10 SHOOTER SAEED MULTI-BAND LIGATOR

Description of Event or Problem

DURING AN ENDOSCOPIC BAND LIGATION PROCEDURE FOR INTERNAL HEMORRHOIDS, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE RELEASED A BAND, WHICH BECAME STUCK, CAUSING THE ENDOSCOPE TO BEND. THE LIGATION DEVICE WAS REMOVED, AND THE BAND WAS PUSHED FORWARD AS A WHOLE. IT THEN RELEASED NORMALLY. HOWEVER, IT BECAME STUCK AGAIN. THE DEVICE WAS RETRACTED AND THEN CHANGED TO A NEW COOK LIGATOR DEVICE TO COMPLETE THE PROCEDURE. OTHER THAN THE DEPLOYED BANDS, A 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 PLASTIC BAG WITH AN OPEN BOX AND TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. THE HANDLE, IRRIGATION ADAPTER, TRIGGER CORD WITH THE BARREL AND ONE BAND ON IT RETURNED. THE PHOTO PROVIDED SHOWS THE BARREL WITH ONE BAND REMAINING ON IT, THE BAND HAS MOVED ALONG THE BARREL AS IF ATTEMPTED DEPLOYMENT, AND THE BARREL IS STILL ATTACHED TO THE TRIGGER CORD. OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE TRIGGER CORD RETURNED WITH ONE BAND REMAINING ON THE BARREL. THE BAND HAD MOVED ALONG THE BARREL AS IF DEPLOYMENT HAD BEEN ATTEMPTED. A FUNCTIONAL TEST WAS PERFORMED ON THE REMAINING BAND 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 BAND WAS FIRED. WHEN THE BAND WAS DEPLOYED, THERE SIGNIFICANT RESISTANCE ENCOUNTERED DURING DEPLOYMENT. A VISUAL EXAMINATION OF THE DEVICE WAS PERFORMED. THE TRIGGER CORD WAS EXAMINED AND ALL TWENTY DEPLOYMENT BEADS WERE PRESENT. THE BEADS WERE VERIFIED FOR CORRECT LOCATION USING BEAD INSPECTION PLATE; ONE OF THE BEADS HAD MOVED ALONG THE TRIGGER CORD, BUT THE OTHER BEADS WERE IN THE CORRECT LOCATION. THIS MOST LIKELY OCCURRED DURING THE DIFFICULT DEPLOYMENT ATTEMPTS. 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 BETWEEN THE KNOTS AND IS WITHIN THE ESTABLISHED TOLERANCE. 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 EVALUATION OF THE RETURNED DEVICE CONFIRMED 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. 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.