SINGLE USE LOOP CUTTER FS-410

Description of Event or Problem

AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER, THAT A PATIENT EXHIBITED BLEEDING AND HEMATOMA, DURING SUTURING AFTER AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). BULGING OF THE SURROUNDING MUCOSA WAS OBSERVED, SO TWO V-LOC SUTURES WERE USED. THE PHYSICIAN TRIED TO CUT THE EXCESS THREAD OF THE V-LOC WITH THE SINGLE USE LOOP CUTTER FS-410, BUT IT INITIALLY DID NOT OPEN. THE PHYSICIAN WAS EVENTUALLY ABLE TO OPEN IT. AND HE WAS ABLE TO CUT THE THREAD AND COLLECT THE LOOP CUTTER. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

Additional Manufacturer Narrative

THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION IS BEING REQUESTED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE DEVICE WAS MANUFACTURED IN APRIL 2022, BUT THE SPECIFIC DATE IS UNKNOWN. BASED ON THE RESULTS OF THE INVESTIGATION RESULTS OF THE SIMILAR COMPLAINT IN THE PAST, AN ATTEMPT WAS POSSIBLY MADE TO CUT THE SUTURE WITHOUT THE SUTURE BEING ON BOTH SIDES OF THE LOOP HANGER. THIS MIGHT HAVE CAUSED THE SUTURE TO BE CAUGHT IN THE CUTTER STORAGE PART. AS A RESULT, THE CUTTER COULD NOT BE OPENED. HOWEVER, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/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RELATIONSHIP BETWEEN THE LOOP AND LOOP HANGER, OR THE SUTURE AND LOOP HANGER, THIS INSTRUMENT MAY BECOME UNABLE TO BE WITHDRAWN FROM THE PATIENT BODY WHEN THE LOOP OR THE SUTURE IS CAUGHT BY THE CUTTER STORAGE PART.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. DEPENDING ON THE POSITIONAL RELATIONSHIP BETWEEN THE LOOP AND THE LOOP RECEIVING PART, OR THE SUTURE AND THE LOOP RECEIVING PART, THE LOOP OR SUTURE MAY GET CAUGHT IN THE CUTTER HOUSING AND BE UNABLE TO BE PULLED OUT FROM THE BODY. WHEN USING THIS PRODUCT, PLEASE FULLY UNDERSTAND THE POSSIBILITY OF LOOPS OR SUTURE GETTING CAUGHT. ¿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 A LOOP OR SUTURE GETS CAUGHT IN THE TIP AND YOU CANNOT PULL THIS PRODUCT OUT OF YOUR BODY, SEE "12 EMERGENCY PROCEDURES." ¿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. BE SURE TO PERFORM THE FOLLOWING PREPARATIONS AND INSPECTIONS BEFORE USE. IF ANY ABNORMALITY IS SUSPECTED, DO NOT USE AND USE A SPARE PRODUCT. USING THIS PRODUCT WITH SUSPECTED ABNORMALITIES MAY NOT ONLY CAUSE IT TO MALFUNCTION, BUT MAY ALSO LEAD TO PERFORATION, MAJOR BLEEDING, DAMAGE TO MUCOUS MEMBRANES, ETC., AS WELL AS DAMAGE TO THE DEVICE OR LOSS OF FUNCTIONALITY. ¿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¿. PLACE THE LOOP OR SUTURE ON BOTH SIDES OF THE LOOP HOLDER SO THAT IT IS AS PERPENDICULAR TO THE CUTTER AS POSSIBLE AND CUT (SEE FIG. 3(A)). IF THE LOOP OR SUTURE IS NOT PLACED CORRECTLY, NOT ONLY WILL IT NOT BE POSSIBLE TO CUT THE LOOP OR SUTURE, BUT THE LOOP OR SUTURE MAY GET CAUGHT IN THE CUTTER COMPARTMENT AND PREVENT THE PRODUCT FROM BEING REMOVED FROM THE BODY. (REFER TO FIG. 3 (B) AND (C)) IF THE PRODUCT CANNOT BE PULLED OUT FROM THE BODY, REFER TO "12 EMERGENCY MEASURES". ¿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¿. DO NOT CUT LOOPS OR SUTURES WHEN THE ENDOSCOPE IS NOT IN SIGHT. A LOOP OR SUTURE MAY GET CAUGHT IN THE CUTTER COMPARTMENT AND PREVENT THE PRODUCT FROM BEING REMOVED FROM THE BODY. IN ADDITION, IT MAY LEAD TO PERFORATION, HEAVY BLEEDING, MUCOUS MEMBRANE DAMAGE, ETC., AND MAY LEAD TO DAMAGE TO THE ENDOSCOPE OR THIS PRODUCT. IF THE PRODUCT CANNOT BE PULLED OUT FROM THE BODY, REFER TO "12 EMERGENCY MEASURES". ¿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. IF THIS PRODUCT CANNOT BE PULLED OUT FROM THE BODY, JUDGE FROM A PROFESSIONAL STANDPOINT AND TAKE APPROPRIATE MEASURES. FORCIBLE WITHDRAWAL MAY LEAD TO BLEEDING AND MUCOUS MEMBRANE DAMAGE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.