LOOP CUTTER

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION AND A DEVICE EVALUATION. UPDATED FIELDS- B5, D4, D8, D9, H2, H3, H4, H6, H11. CORRECTION: D10. THE DEVICE WAS RETURNED TO OLYMPUS AND THE REPORTED FAILURE WAS CONFIRMED. THE LOOP GOT CAUGHT IN THE DISTAL END AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, IT IS LIKELY THAT THE LOOP WAS NOT PROPERLY POSITIONED ON BOTH EDGES OF THE LOOP HANGER AT THE TIME OF CUTTING. THIS MISALIGNMENT CAUSED THE LOOP TO BECOME CAUGHT BETWEEN THE CUTTER AND THE LOOP HANGER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A THERAPEUTIC POLYPECTOMY UNDER SEDATION, THE LOOP CUTTER MALFUNCTIONED WHEN ITS DISTAL END FAILED TO MOVE AFTER LIGATING. THE HANDLE SLIDER PART MOVED, BUT THE DISTAL END DID NOT MOVE AT ALL. WITH THE LOOP STUCK IN A KINKED POSITION, THE TEAM ATTEMPTED TO CUT THE ROOT OF THE LOOP HANDLE AND REMOVE THE SCOPE, BUT THE LOOP CUTTER¿S MAIN BODY APPEARED TO FALL OUT DURING REMOVAL. A SECOND SCOPE WAS THEN INSERTED, AND THE SAME LOOP CUTTER DEVICE WAS USED TO CUT THE LOOP. THIS EVENT CAUSED A DELAY OF MORE THAN 30 MINUTES, BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY HARM TO THE PATIENT.