LOOP CUTTER

Description of Event or Problem

AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, WHEN CUTTING THE THREAD DURING A CASE, NORMALLY A SPECIAL CUTTER WOULD BE USED BUT INSTEAD A LOOP CUTTER WAS USED. AT THAT TIME, THE THREAD BECAME LODGED IN THE BODY AND BECAME TEMPORARILY STUCK INSIDE THE BODY. THE THREAD WAS CUT WITH AN ELECTRIC SCALPEL TO RELIEVE THE INCARCERATION. THE THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION WAS COMPLETED USING THE SUBJECT DEVICE. WHEN THE PERSON IN CHARGE OF THE FACILITY CHECKED, THE FACILITY WAS NOT AWARE THERE WAS A DEDICATED LOOP CUTTER. THERE IS A PLAN TO PROVIDE DETAILED EXPLANATIONS FOR THE FACILITY AT A LATER DATE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION; THEREFORE, THE EVENT AND CONDITION OF DEVICE WAS UNABLE TO BE CONFIRMED. THE DEVICE LOT NUMBER WAS UNKNOWN, DEVICE HISTORY RECORD (DHR) 29-K-38K LOT FOR THE PAST YEAR (FROM EVENT DATE) WAS REVIEWED. NO ABNORMALITIES WERE DETECTED IN THE DHR RELATED TO THE REPORTED PHENOMENON. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE FOLLOWING: ·THE DEVICE COULD NOT BE CONFIRMED SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS. ·THE DEVICE HISTORY RECORD FOR THE LOT INDICATED NO ANOMALY WITH THE EVENT-RELATED ITEMS. THE INSTRUCTION MANUAL PROVIDES THE FOLLOWING: ¿¿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. ¿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 SAFELY 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 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 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. ¿DO NOT CUT THE LOOP UNLESS YOU HAVE A CLEAR ENDOSCOPIC FIELD OF VIEW. THIS COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.