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.

Description of Event or Problem

IT WAS REPORTED DURING SEDATION OF A THERAPEUTIC ENDOSCOPIC MUCOSAL RESECTION WHEN ATTEMPTING TO CUT THE LIGATURE THREAD WITH A LOOP CUTTER, THE LOOP CUTTER BLADE BECAME ENTANGLED WITH THE THREAD AND STUCK. CUT THE HAND SIDE OF THE LOOP CUTTER AND REMOVE THE ENDOSCOPE. A NEW LOOP CUTTER WAS THEN BROUGHT OUT TO CUT AND RESOLVE THE LIGATURE THREADS AGAIN. THIS CAUSED A SURGICAL PROLONGATION OF LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

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, D9, H3, H4, H6, H11. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT IT WAS NOT THE SEWING THREAD BUT THE LOOP THAT HAD GOTTEN CAUGHT IN THE DISTAL END. THE LOOP SHOULD BE POSITIONED ON BOTH SIDES OF THE LOOP HOLDER DURING CUTTING; HOWEVER, IN THE SUBJECT DEVICE, THE LOOP WAS NOT PLACED ON EITHER SIDE. AFTER REMOVING THE LOOP, THE CONDITION OF THE CUTTER BLADES WAS INSPECTED. NO VISIBLE DAMAGE, SUCH AS CHIPPING, WAS FOUND, AND NO DEFECTS THAT COULD LEAD TO POOR CUTTING PERFORMANCE WERE OBSERVED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE LOOP BECAME CAUGHT BECAUSE IT WAS NOT PROPERLY POSITIONED ON BOTH SIDES OF THE LOOP HOLDER AT THE TIME OF CUTTING. THE INSTRUCTIONS FOR USE (IFU) CAUTIONS "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.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. UPDATED FIELDS: H6. 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. BASED ON THE EVENT DESCRIPTION, IT IS PRESUMED THAT THE CUTTER BECAME IMMOBILE DUE TO AN ATTEMPT TO CUT SEWING THREADS, WHICH ARE NOT INTENDED FOR THIS PRODUCT, RESULTING IN THE SEWING THREADS BECOMING STUCK IN THE DISTAL END. FURTHERMORE, IT IS EXPLICITLY STATED IN THE INSTRUCTION MANUAL THAT THE SEWING THREADS SHOULD NOT BE CUT, AND NO ISSUES WERE IDENTIFIED WITH THE LABELING. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: GW8636 23: INTENDED USE: THIS INSTRUMENT HAS BEEN DESIGNED TO BE USED WITH AN OLYMPUS ENDOSCOPE. IT IS USED TO CUT THE RESIDUAL END OF THE OLYMPUS LOOP USED FOR LIGATING TISSUE WITHIN THE DIGESTIVE TRACT. DO NOT USE THIS INSTRUMENT FOR ANY OTHER PURPOSE. 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 USE THE INSTRUMENT TO CUT ANY OBJECTS OTHER THAN THE SURPLUS OF OLYMPUS LOOP (E.G., MAJ-254, MAJ-340). IF ANYTHING, OTHER THAN THE SURPLUS OF THE LOOP IS CUT, THE BLADES MAY BE DAMAGED AND UNABLE TO PERFORM PROPERLY, THE CUT OBJECT MAY BE CAUGHT IN THE TIP OF THE INSTRUMENT, AND IT MAY BECOME DIFFICULT TO SAFETY REMOVE THE INSTRUMENT FROM THE BODY. SUCH OBJECTS OTHER THAN THE SURPLUS OF LOOP MAY INCLUDE, STENT WIRE, SEWING THREADS, AND LOOP STOPPERS. DO NOT USE THE LOOP CUTTER TO CUT ANYTHING OTHER THAN THE LOOP. IF YOU CUT ANY OTHER OBJECT, IT MAY GET CAUGHT IN THE DISTAL END. THIS COULD MAKE IT DIFFICULT OR IMPOSSIBLE TO REMOVE IT FROM THE PATIENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.