10 SHOOTER SAEED MULTI-BAND LIGATOR

Additional Manufacturer Narrative

THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT OF NEW INFORMATION.

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 USER FLIPPED THE ENDOSCOPE AND RELEASED ONE BAND AND PREPARING TO RELEASE SECOND BAND, THE BAND COULD NOT BE RELEASED. AFTER CHANGING THE ENDOSCOPE POSITION FROM REVERSE TO FORWARDING, IT STILL COULD NOT BE RELEASED. USER RETRACTED THE DEVICE FROM PATIENT BUT IT STILL COULD NOT BE RELEASED. AFTER REINSTALLING IT AGAIN, THE REMAINING BANDS COULD NOT BE RELEASED [UNABLE TO DEPLOY BANDS - SUBJECT OF REPORT]. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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: 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. SOME BANDS WERE NOT RETURNED WITH THE DEVICE. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE. A VISUAL INSPECTION SHOWED THAT 6 BANDS REMAINED ON THE BARREL, ONE OF THE BLACK BANDS HAD MOVED SLIGHTLY ALONG THE BARREL, AND A PORTION OF THE TRIGGER CORD HAD COME AWAY FROM THE BARREL AND WAS NO LONGER PROPERLY RETAINED UNDER THE BANDS. ALL TWENTY OF THE DEPLOYMENT BEADS ARE PRESENT ON THE TRIGGER CORD. CORRECT BEAD PLACEMENT COULD NOT BE VERIFIED DUE TO THE TRIGGER CORD STILL BEING ATTACHED TO THE BARREL. THE BEADS WERE EXAMINED USING MAGNIFICATION AND FOUND TO BE CORRECTLY FILLED AND HAD NO EVIDENCE OF EXCESS FLASH. THE LENGTH OF THE TRIGGER CORD WAS MEASURED BETWEEN THE KNOTS WHICH IS WITHIN THE ESTABLISHED TOLERANCE. THE TRIGGER CORD WAS INTACT AND NOT BROKEN. A FUNCTION TEST WAS NOT PERFORMED TO DEPLOY THE REMAINING BAND DUE TO THE CONDITION OF THE RETURNED DEVICE. THE SUBASSEMBLY HISTORY RECORD FOR THE TRIGGER CORD SAID TO BE INVOLVED WAS REVIEWED. THE QUALITY CONTROL TENSILE TEST PERFORMED ON A SAMPLE OF THE MANUFACTURED UNITS MET THE ACCEPTANCE CRITERIA. 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. ONE LEG OF THE TRIGGER CORD WAS FOUND TO BE EXTENDED FROM UNDERNEATH THE BANDS AND IS THE MOST LIKELY CAUSE OF DIFFICULT DEPLOYMENT. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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.