BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 20134128 · Received September 4, 2024

    Report

    Report Number
    9614641-2024-01765
    Event Type
    Injury
    Date Received
    September 4, 2024
    Report Date
    October 24, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    MND
    UDI-DI
    04953170368615
    PMA / PMN Number
    CLASS2EXMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A3: UNABLE TO UNCHECK FEMALE. NO INDICATION THE EVENT INVOLVED FEMALE AT THE TME OF THIS REPORT. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000399. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 (B5 AND G2). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION AND BASED ON THE INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE REPORTED EVENTS MIGHT BE ONE OF THE FOLLOWING: MECHANISM 1: 1) THE LOOP WAS PLACED AROUND THE BODY TISSUE. 2) THE TUBE SHEATH WAS PUSHED FORWARD, AND THE TISSUE WAS TEMPORARILY LIGATED WITH THE DISTAL END OF THE TUBE SHEATH. 3) THE SLIDER WAS PULLED TO TIGHTEN THE LOOP. 4) BECAUSE THE DISTAL END OF THE COIL WAS NOT EXTENDED FROM THE TUBE SHEATH WHEN THE SLIDER WAS PUSHED, THE LOOP DISENGAGED FROM THE HOOK INSIDE THE TUBE SHEATH. 5) THE HOOK PROTRUDED FROM THE DISTAL END OF THE COIL SHEATH, CAUSING THE LOOP TO MOVE TOWARD THE HANDLE SIDE AND ENTER THE COIL SHEATH. 6) PULLING THE HOOK CAUSED BOTH THE HOOK AND THE LOOP TO BE DRAWN INTO THE COIL SHEATH TOGETHER. AS A RESULT, THE LOOP BECAME TRAPPED BETWEEN THE HOOK AND THE INNER SURFACE OF THE COIL, PREVENTING IT FROM MOVING. 7) BECAUSE THE LOOP IS TRAPPED BETWEEN THE HOOK AND THE INNER SURFACE OF THE COIL, PUSHING THE SLIDER DOES NOT RELEASE THE LOOP. MECHANISM 2: 1) THE SHEATH WAS BENT NEAR THE HANDLE. 2) THE OPERATING WIRE COULD NOT MOVE BECAUSE SLIDING RESISTANCE BETWEEN THE SHEATH AND THE OPERATING WIRE INCREASED. 3) THE OPERATING PIPE DEFORMED AND BROKE BECAUSE THE SLIDER WAS FORCEFULLY OPERATED. 4) DUE TO ABOVE, THE LOOP COULD NOT DETACH FROM THE HOOK. HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿DO NOT STRIKE OR CRUSH THE COIL SHEATH DURING OPERATION. DOING SO CAN DAMAGE THE DISTAL END OF THE COIL SHEATH, WHICH COULD MAKE IT IMPOSSIBLE TO DETACH THE LOOP AFTER LIGATION. IN THIS CASE, REFER TO SECTION 12, ¿EMERGENCY TREATMENT¿ AND AS SHOWN ¿EQUIPMENT TO BE USED IN AN EMERGENCY¿ IN THIS MANUAL.¿ ¿DO NOT REMOVE THE LOOP FROM THE HOOK WHILE THE COIL SHEATH IS NOT EXTENDED FROM THE TUBE SHEATH. OTHERWISE, THE LOOP MAY BE TANGLED WITH THE HOOK AND BECOME IMPOSSIBLE TO REMOVE. IN THIS CASE, REFER TO SECTION 12, ¿EMERGENCY TREATMENT¿ AND AS SHOWN ¿EQUIPMENT TO BE USED IN AN EMERGENCY¿ IN THIS MANUAL.¿ ¿DO NOT HOLD THE LOOP WITH THE DISTAL END OF THE TUBE SHEATH WHILE THE LOOP IS SURROUNDING THE TISSUE. OTHERWISE, WHEN THE TISSUE IS LIGATED, THE LOOP MAY BE DETACHED FROM THE HOOK IN THE TUBE SHEATH AND TANGLED WITH THE HOOK. THAT MAY MAKE THE LOOP IMPOSSIBLE TO REMOVE. IN THIS CASE, REFER TO SECTION 12, ¿EMERGENCY TREATMENT¿ AND AS SHOWN ¿EQUIPMENT TO BE USED IN AN EMERGENCY¿ IN THIS MANUAL.¿ ¿NEVER USE EXCESSIVE FORCE TO OPERATE THE INSTRUMENT. THIS COULD DAMAGE THE INSTRUMENT.¿ ¿STRAIGHTEN OUT THE PORTION OF THE INSTRUMENT THAT EXTENDS FROM THE BIOPSY VALVE.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED AT THE END OF A THERAPEUTIC COLONOSCOPY PROCEDURE, THE HANDLE FOR DEPLOYMENT OF THE SINGLE USE LIGATING DEVICE SEPARATED AND INTERNAL PARTS CAME OUT. THE DEVICE WAS STUCK IN THE PATIENT'S SIGMOID COLON. THE ISSUE CAUSED A DELAY IN THE PROCEDURE OF 55 MINUTES. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA AS THE CUSTOMER REPORTED THEY USE PROPOFOL AND LIDOCAINE FOR SEDATION, THE PATIENT WAS BREATHING ON THEIR OWN. THE CUSTOMER NOTED THAT THE PHYSICIAN KNEW HOW TO REMOVE THE DEVICE SAFELY FROM THE PATIENT WITHOUT INJURY. ANOTHER PHYSICIAN WAS CALLED INTO THE ROOM FOR ASSISTANCE. A GASTROINTESTINAL (GI) TECH HELD THE WIRE AS BOTH PHYSICIANS USED PLIERS AND A CUTTER TO GET THE HANDLE OF THE DEVICE OFF TO BE ABLE TO REMOVE THE SCOPE. ONCE THE SCOPE WAS REMOVED, THE DEVICE REMAINED IN THE PATIENT, MINUS THE HANDLE, AND WAS HELD BY THE GI TECH. THE PHYSICIAN REINSERTED THE SCOPE AND USED A SNARE TO GET BOTH THE POLYP AND THE LIGATING DEVICE OFF WITH A CLEAN CUT. THE SNARE AND SCOPE WERE THEN REMOVED WITH NO ISSUE. THE LIGATING DEVICE WAS REMOVED, AND THE POLYP WAS OBTAINED. THE PROCEDURE WAS THEN COMPLETED. THERE WAS NO REPORTED PATIENT HARM. FOLLOW-UP RECEIVED IDENTIFIED THAT 3 SIMILAR EVENTS OCCURRED IN THE FACILITY.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FOR A SIMILAR EVENT THAT OCCURRED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080914 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE MND AOMORI OLYMPUS CO., LTD. HX-400U-30 04953170368615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention