LOOP CUTTER

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. E1: (B)(6). THIS REPORT IS LINKED TO PATIENT IDENTIFIER (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT DURING A POLYPECTOMY, AFTER USING THE LIGATING DEVICE, WHILE ATTEMPTING TO CUT THE LIGATING LOOP WITH A LOOP CUTTER, THE LOOP CUTTER GOT STUCK AND COULD NOT BE RELEASED. THE HANDLE OF THE LOOP CUTTER WAS CUT AND DURING AN ATTEMPT TO REMOVE THE SCOPE, THE SIDE OF THE LOOP CUTTER GOT CAUGHT IN THE DEVICE (AT THE JUNCTION OF THE BIOPSY CHANNEL), AND THE SCOPE COULD NOT BE REMOVED. THE SCOPE WAS RELEASED BY CUTTING THE SCISSORS FORCEPS (LOOP CUTTER) WITH PLIERS. THE SCOPE WAS REMOVED, THEN REINSERTED, AND THE POLYP WAS RESECTED. THE LOOP WAS THEN CUT, AND THE LOOP CUTTER WAS REMOVED. THE PROCEDURE WAS EXTENDED BY ABOUT 30 MINUTES AND COMPLETED WITH NO ADDITIONAL PATIENT IMPACT OR HARM.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION, AND DEVICE EVALUATION BASED ON THE APPROVED FINAL INVESTIGATION. UPDATED FIELDS: D4, D8, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. THE LOOP SHOULD BE POSITIONED ON BOTH EDGES OF THE LOOP HANGER DURING CUTTING; HOWEVER, IN THE SUBJECT DEVICE, THE LOOP WAS NOT PLACED ON EITHER SIDE. ADDITIONALLY, THE INSERTION PORTION WAS FOUND TO HAVE BEEN CUT AT 1,821 MM FROM THE DISTAL TIP AND 40 MM FROM THE HANDLE. THE CUT SURFACE ON THE HANDLE-SIDE, WHICH CORRESPONDS TO THE PORTION THAT BECAME CAUGHT AT THE BRANDING SECTION OF THE ENDOSCOPE, WAS EXAMINED AND A PROTRUSION WAS OBSERVED ON THE CUT SURFACE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE REPORTED EVENT OCCURRED BECAUSE 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. ALTHOUGH AN ATTEMPT WAS MADE TO REMOVE THE ENDOSCOPE ALONE FROM THE BODY, IT IS LIKELY THAT THE PROTRUSION ON THE COIL¿S CUT SURFACE CONTRIBUTED TO THE SCOPE BECOMING CAUGHT AT THE BRANCHING SECTION DURING REMOVAL. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: BEFORE EACH CASE, PREPARE AND INSPECT THE INSTRUMENT AS INSTRUCTED BELOW. INSPECT OTHER EQUIPMENT TO BE USED WITH THE INSTRUMENT AS INSTRUCTED IN THEIR RESPECTIVE INSTRUCTION MANUALS. SHOULD THE SLIGHTEST IRREGULARITY BE SUSPECTED, DO NOT USE THE INSTRUMENT; CONTACT OLYMPUS. DAMAGE OR IRREGULARITY MAY COMPROMISE PATIENT OR USER SAFETY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE. DO NOT TRY TO CUT THE LOOP THAT IS NOT POSITIONED ON BOTH EDGES OF THE LOOP HANGER AS PLUMB AS POSSIBLE FOR THE BLADE. IT MAY MAKE CUTTING THE LOOP IMPOSSIBLE, OR RESULT IN THE LOOP GETTING CAUGHT IN THE DISTAL END OF THE INSTRUMENT, WHICH COULD MAKE IT DIFFICULT OR IMPOSSIBLE TO REMOVE FROM THE PATIENT. IN THIS CASE, USE PLIERS TO CUT THE INSERTION PORTION OF THE INSTRUMENT WHERE IT EXTENDS FROM THE BIOPSY VALVE OF THE ENDOSCOPE. REMOVE THE ENDOSCOPE FROM THE BODY, THEN REINSERT THE ENDOSCOPE AND CUT THE LOOP WITH A SPARE LOOP CUTTER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.