SINGLE USE LOOP CUTTER FS-410

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS NOT CONFIRMED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE LOOP CUTTER GOT STUCK IN THE STENT AND WAS TEMPORARILY UNABLE TO BE REMOVED. THIS OCCURRED WHEN THE CUSTOMER ATTEMPTED TO CUT A METALLIC STENT DURING A RESPIRATORY SURGERY. THE DOCTOR MOVED THE SLIDER IN HIS HAND SEVERAL TIMES AND IT CAME OFF, BUT IN THE END THE TIP OF THE LOOP CUTTER COULD NOT BE OPENED AT ALL. THE ISSUE WAS FOUND DURING THE CANCELLED PROCEDURE. THE PROCEDURE WAS TEMPORARILY SUSPENDED. THE PROCEDURE WILL CONTINUE AS SOON AS NEW FORCEPS ARE AVAILABLE TO CUT THE STENT. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 MONTHS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: IT IS LIKELY THAT THE REPORTED PHENOMENON OCCURRED BECAUSE THE USER ATTEMPTED TO CUT STENT THAT WERE NOT INTENDED FOR USE. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: DUE TO THE POSITIONING RELATIONSHIP BETWEEN THE LOOP AND LOOP HANGER, OR THE SUTURE AND LOOP HANGER, THIS INSTRUMENT MAY BECOME UNABLE TO BE WITHDRAWN FROM THE PATIENT BODY WHEN THE LOOP OR THE SUTURE IS CAUGHT BY THE CUTTER STORAGE PART. HAVE A FULL UNDERSTANDING OF THE POTENTIAL OF THE LOOP OR THE SUTURE CAUGHT AT THE DISTAL END BEFORE USING THIS INSTRUMENT. IF THIS INSTRUMENT CANNOT BE WITHDRAWN FROM THE PATIENT BODY BECAUSE THE LOOP OR THE SUTURE IS CAUGHT BY THE DISTAL END, REFER TO CHAPTER 12, ¿EMERGENCY TREATMENT¿. BEFORE USE, PREPARE AND INSPECT THE INSTRUMENT AS INSTRUCTED BELOW. SHOULD ANY IRREGULARITY BE OBSERVED, DO NOT USE THE INSTRUMENT; USE A SPARE INSTEAD. 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. POSITION THE LOOP OR THE SUTURE ON BOTH EDGES OF THE LOOP HANGER SO AS TO MAKE IT AS PLUMB AS POSSIBLE WITH RESPECT TO THE DISTAL END AND CUT IT (SEE FIGURE 3 (A)). DO NOT TRY TO CUT THE LOOP OR A SUTURE THAT IS NOT POSITIONED ON BOTH EDGES OF THE LOOP HANGER (SEE FIGURE 3 (B)). IT MAY MAKE CUTTING THE LOOP OR THE SUTURE IMPOSSIBLE, OR RESULT IN THE LOOP OR THE SUTURE GETTING CAUGHT IN THE CUTTER STORAGE PART OF THE INSTRUMENT, WHICH COULD MAKE IT DIFFICULT OR IMPOSSIBLE TO REMOVE FROM THE PATIENT. (SEE FIGURE 3 (B), (C)) IF THIS INSTRUMENT CANNOT BE WITHDRAWN FROM THE PATIENT BODY BECAUSE THE LOOP OR THE SUTURE IS CAUGHT BY THE DISTAL END, REFER TO CHAPTER 12, "EMERGENCY TREATMENT". DO NOT CUT THE LOOP OR THE SUTURE UNLESS YOU HAVE A CLEAR ENDOSCOPIC FIELD OF VIEW. THIS COULD CAUSE THE LOOP OR THE SUTURE GETTING CAUGHT IN THE CUTTER STORAGE PART OF THE INSTRUMENT, AND IT MAY BECOME DIFFICULT TO SAFELY REMOVE THE INSTRUMENT FROM THE BODY. IT MAY ALSO CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES, OR MUCOUS MEMBRANE DAMAGE, OR THE ENDOSCOPE AND/OR INSTRUMENT DAMAGE. IF THIS INSTRUMENT CANNOT BE WITHDRAWN FROM THE PATIENT BODY BECAUSE THE LOOP OR THE SUTURE IS CAUGHT BY THE DISTAL END, REFER TO CHAPTER 12, "EMERGENCY TREATMENT". IF THIS INSTRUMENT CANNOT BE WITHDRAWN FROM THE PATIENT BODY, MAKE A JUDGMENT FROM THE SPECIALIST¿S VIEW. FORCIBLE WITHDRAWAL COULD LEAD TO BLEEDING OR MUCOUS MEMBRANE DAMAGE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.