SINGLE USE LOOP CUTTER FS-410

Additional Manufacturer Narrative

THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED, THE LOOP CUTTER FS-410 EXHIBITED LOOP CUTTER GOT STUCK IN THE SUTURE. THE ISSUE IS UNKNOWN AS TO WHEN IT OCCURRED. THE CUSTOMER HAD TO GO IN WITH A SECOND SCOPE AND ACTUAL ENDO SCISSORS TO FREE THE OTHER SCOPE/LOOP. THIS COULD HAVE RESULTED IN PATIENT INJURY; HOWEVER, THE PATIENT WAS OKAY OTHERWISE. THERE WERE NO REPORTS OF PATIENT HARM, INJURY, OR DEATH.

Description of Event or Problem

IT WAS REPORTED THAT THE ISSUE OCCURRED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH J-TUBE REMOVAL PROCEDURE (J-TUBE WAS PREVIOUSLY SUTURED TO THE SMALL BOWEL WALL TO REDUCE MIGRATION).

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) 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 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS BECAUSE IT WAS DISCARDED BY THE FACILITY. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THAT AN ATTEMPT WAS LIKELY MADE TO CUT THE SUTURE WITHOUT THE SUTURE BEING ON BOTH SIDES OF THE LOOP HANGER. THIS MAY HAVE CAUSED THE SUTURE TO GET CAUGHT IN THE CUTTER STORAGE PART OF THE DEVICE. AS A RESULT, THE SUTURE COULD NOT BE CUT, AND THE SUBJECT DEVICE WAS UNABLE TO BE REMOVED. HOWEVER, THE ROOT CAUSE OF THE EVENT COULD NOT BE IDENTIFIED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATES: ¿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RELATIONSHIP BETWEEN THE LOOP AND LOOP HANGER, OR THE SUTURE AND LOOP HANGER, THIS INSTRUMENT MAY BECOME UNABLE TO BE WITHDRAWN FROM THE PATIENT BODY WHEN THE LOOP OR THE SUTURE IS CAUGHT BY THE CUTTER STORAGE PART.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OF THE LOOP OR THE SUTURE CAUGHT AT THE DISTAL END BEFORE USING THIS INSTRUMENT.¿ ¿IF THIS INSTRUMENT CANNOT BE WITHDRAWN FROM THE PATIENT BODY BECAUSE THE LOOP OR THE SUTURE IS CAUGHT BY THE DISTAL END, REFER TO CHAPTER 12, ¿EMERGENCY TREATMENT¿.¿ ¿BEFORE USE, PREPARE AND INSPECT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 EITHER 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 TO GET 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, 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.¿ THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. B5 UPDATED ACCORDINGLY. AN UPDATE HAS BEEN MADE TO E1, E2, E3, AND G2. ALSO, A CORRECTION HAS BEEN MADE TO D8 AND H8 FROM THE PREVIOUS SUBMISSIONS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT DEVICE WAS USED BY THE CUSTOMER TO REMOVE THE SUTURES OF THE J-TUBE INSTEAD OF ENDO SCISSORS. THE SUTURE THEN GOT STUCK IN THE LOOP AND THE CUSTOMER HAD TO GO IN WITH A SECOND SCOPE AND ACTUAL ENDO SCISSORS TO FREE THE OTHER SCOPE AND LOOP. THE SURGERY WAS PROLONGED FOR ABOUT AN HOUR. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION TO THE INITIAL MDR FOR INFORMATION INADVERTENTLY LEFT OUT AS REFLECTED IN B1, B2, B5, H1, AND H6 FIELDS. UPDATE IS ALSO ADDED TO H10. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER (B)(4).