10 SHOOTER SAEED MULTI-BAND LIGATOR

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. 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.

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 ON (B)(6) 2026, A PATIENT WITH INTERNAL HEMORRHOIDS WAS SCHEDULED TO UNDERGO ENDOSCOPIC LIGATION OF INTERNAL HEMORRHOIDS IN THE ENDOSCOPY ROOM. DURING THE PROCEDURE, THE COOK LIGATION DEVICE ENCOUNTERED DIFFICULTIES IN RELEASE AND THE ENDOSCOPE BECAME DISTORTED. THE FIRST TWO BANDS WERE RELEASED SMOOTHLY, BUT THE THIRD BAND BEGAN TO MALFUNCTION (DIFFICULTY IN RELEASE - SUBJECT OF REPORT). AFTER REPLACING THE LIGATION DEVICE AND ENDOSCOPE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS ADVERSE EVENT DID NOT CAUSE ANY ADVERSE REACTIONS TO THE PATIENT. 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.