SINGLE USE LOOP CUTTER FS-410

Additional Manufacturer Narrative

E1: (B)(6). 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 COLONOSCOPY AND POLYP REMOVAL, THE ENDOLOOP PLACEMENT WAS NOT WHAT THE PHYSICIAN QUITE WANTED SO THE DECISION WAS MADE TO USE THE LOOP CUTTER TO CUT AND TRY AGAIN. DURING THE ATTEMPT TO CUT THE ENDOLOOP WITH A LOOP CUTTER, THE CUTTER INTERNALLY (INSIDE SHEATH) MUST HAVE PULLED AND SNAPPED AS THE LOOP CUTTER WOULD NOT OPEN OR CLOSE, WAS STUCK ON TISSUE, AND THE HANDLE WAS NOT OPENING OR CLOSING THE CUTTER. A WIRE CUTTER WAS USED TO CUT THE SHEATH FROM OUTSIDE THE HANDLE AND PULL OFF THE SCOPE (DO EXCHANGE AND LEAVE THE SHEATH HANGING OUTSIDE THE PATIENT, GO BACK IN, AND INTRODUCE SURGICAL SCISSORS TO PUT THE TISSUE TO RELEASE THE STUCK LOOP CUTTER OFF OF THE PATIENT). THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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.