LOOP CUTTER

Additional Manufacturer Narrative

THE EVALUATION OF THE DEVICE IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT THE DURING A THERAPEUTIC COLORECTAL PROCEDURE, WHEN AN ATTEMPT WAS MADE TO CUT THE LIGATING DEVICE WITH THE LOOP CUTTER, THE LOOP GOT CAUGHT IN THE LOOP RECEIVER AT THE TIP OF THE BLADE AND COULD NOT BE REMOVED. THEREFORE, ANOTHER ENDOSCOPE WAS INSERTED, AND THE LOOP WAS REMOVED FROM THE POLYP WITH BIOPSY FORCEPS MADE BY ANOTHER MANUFACTURER. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE FOLLOWING WAS OBSERVED: THE INSERTION PORTION WAS BUCKLED AT ABOUT 21 CM FROM THE TIP, AND THE LOOPS WERE CAUGHT IN THE CUTTER STORAGE PART OF THE DEVICE. THE CUTTER SECTION DID NOT OPEN OR CLOSE EVEN WHEN THE SLIDER WAS OPERATED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT AN ATTEMPT WAS MADE TO CUT THE LOOP WITHOUT THE LOOP BEING ON BOTH SIDES OF THE LOOP HANGER. THIS MAY HAVE CAUSED THE LOOP TO BE CAUGHT IN THE CUTTER STORAGE PART OF THE DEVICE. AS A RESULT, THE LOOP COULD NOT BE CUT, AND AN UNEXPECTED INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATES: ¿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.¿ ¿ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE.¿ ¿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.¿ ¿DO NOT CUT THE LOOP UNLESS YOU HAVE A CLEAR ENDOSCOPIC FIELD OF VIEW. THIS COULD CAUSE PATIENT INJURIES, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT.¿ ¿IF IT IS DIFFICULT TO CUT TWO LOOPS SIMULTANEOUSLY, CUT THEM ONE AT A TIME. FORCIBLE CUTTING MAY DAMAGE THE LOOP CUTTER.¿ ¿WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, HOLD IT CLOSE TO THE BIOPSY VALVE AND KEEP IT AS STRAIGHT AS POSSIBLE RELATIVE TO THE BIOPSY VALVE. OTHERWISE, THE INSERTION PORTION OF THE INSTRUMENT COULD BE DAMAGED.¿ ¿INSERT THE LOOP CUTTER SLOWLY. ABRUPT INSERTION COULD DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT.¿ THIS SUPPLEMENTAL REPORT INCLUDES AN UPDATE TO H3 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.