BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 14984356 · Received July 12, 2022

    Report

    Report Number
    8010047-2022-11724
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 16, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    UDI-DI
    04953170194641
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WITH MODEL NO. HX-400U-30 WAS RETURNED FOR EVALUATION. THE LOT NUMBER WAS 1YK WITH SUPPLEMENTARY INFORMATION NUMBER OF ¿16¿. (MANUFACTURING DATE:NOVEMBER 16, 2021). DEVICE EVALUATION, THE FOLLOWING WERE NOTED: THE LOOP HAD BEEN ATTACHED TO THE DISTAL ENDO OF THE INSERTION PORTION WHEN IT ARRIVED FOR INVESTIGATION. THE DISTAL END OF THE LOOP WAS CUT. THE OPERATION PIPE OF THE HANDLE SECTION WAS DEFORMED. THE TUBE SHEATH OF THE INSERTION PORTION WAS SEVERED AT APPROXIMATELY 2290MM FROM DISTAL END OF THE INSERTION PORTION. THE COIL SHEATH WAS SEVERED AT APPROXIMATELY 2310MM FROM THE DISTAL END OF THE INSERTION PORTION. THE SEVERED AREAS REVEALED THE SHAPE THAT WERE CUT MECHANICALLY BY USING A TOOL. THE HOOK PRESENTED NO ABNORMALITIES SUCH AS DEFORMATION OR BENDING. WHEN PULLED THE LOOP, THE LOOP WAS DETACHED FROM THE HOOK. THE PROXIMAL SIDE OF THE LOOP WAS DEFORMED AS IF IT HAD BEEN PINCHED. OTHER ABNORMALITIES THAT COULD LEAD TO REPORTED PHENOMENON WERE NOT CONFIRMED. THE DHRS (DEVICE HISTORY RECORDS) FOR THIS PRODUCT HAVE BEEN REVIEWED. DHR REVIEW REVEALED THE LOT HAD PASSED ALL THE EVENT-RELATED INSPECTION ITEMS. PROCESS INSPECTION; QUALITY INSPECTION; NONCONFORMING PRODUCT REPORT. THE IFU (INSTRUCTION FOR USE): THE INSTRUCTION MANUAL CONTAINS THE FOLLOWING DESCRIPTIONS, AND IT WARNS AGAINST THIS EVENT. (GK8332 REV.04). 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¿ ON PAGE 3 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 BE REMOVED. IN THIS CASE, REFER TO SECTION 12, ¿EMERGENCY TREATMENT¿ AND AS SHOWN ¿EQUIPMENT TO BE USED IN AN EMERGENCY¿ ON PAGE 3 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 BE REMOVED. IN THIS CASE, REFER TO SECTION 12, ¿EMERGENCY TREATMENT¿ AND AS SHOWN ¿EQUIPMENT TO BE USED IN AN EMERGENCY¿ ON PAGE 3 IN THIS MANUAL. NEVER USE EXCESSIVE FORCE TO OPERATE THE INSTRUMENT. THIS COULD DAMAGE THE INSTRUMENT. BASED ON THE CONDITION OF THE SUBJECT DEVICE AND SIMILAR CASES IN THE PAST, A LIKELY FACTOR CAUSING THE REPORTED PHENOMENON MIGHT BE THE FOLLOWING: ·THE PROXIMATE SIDE OF THE LOOP WAS TEMPORARILY RETRACTED INTO THE COIL SHEATH, AND THE LOOP WAS CAUGHT IN BETWEEN THE COIL SHEATH AND THE HOOK. THIS PREVENTED THE SLIDER FROM MOVING AND THE LOOP COULD NOT BE DETACHED FROM THE COIL SHEATH. UNDER THESE CIRCUMSTANCES, THE SLIDER WAS FORCEFULLY OPERATED. AS A RESULT, THE OPERATING PIPE WAS BENT AND BROKEN. DETACHMENT FAULT OF THE LOOP WAS LIKELY CAUSED BY THE MECHANISM BELOW. 1) THE LOOP WAS DETACHED FROM THE HOOK WHILE THE COIL SHEATH WAS BEING RETRACTED INTO THE TUBE SHEATH, OR THE LOOP WAS HANG ON TO THE TISSUE AND IT WAS POSITIONALLY FIXED AT THE DISTAL END OF THE TUBE. AS A RESULT, THE LOOP WAS UNABLE TO RELEASE. 2) THE TUBE SHEATH WAS PULLED TOWARD THE PROXIMATE SIDE WHILE THE HOOK WAS EXTENDED FROM THE DISTAL END OF THE COIL SHEATH. 3) SINCE THE TUBE SHEATH WAS PULLED TOWARD THE PROXIMATE SIDE, CAUSING THE TUBE TO PULL THE LOOP. THIS CAUSED THE LOOP TO RETRACT INTO THE COIL SHEATH. AS A RESULT, THE LOOP WAS CAUGHT IN BETWEEN THE HOOK AND INNER SURFACE OF THE COIL, AND THE LOOP STOPPED MOVING. 4) THE SLIDER WAS FORCEFULLY OPERATED IN STATE OF # 3 DESCRIPTION ABOVE CAUSING THE OPERATION PIPE TO BREAK. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE THE ADDITIONAL INFORMATION OF THE DEVICE UDI.

    Description of Event or Problem · 0

    IT WAS REPORTED, DURING THE PROCEDURE, WHEN THE USER HOOKED A LOOP ON THE POLYP, IT COULD NOT BE RELEASED. THE USER CUT THE HANDLE OF THE INDWELLING SNARE WITH PLIERS AND REMOVED THE ENDOSCOPE. THE USER REINSERT THE ENDOSCOPE, CUT AND REMOVED THE SNARE WITH A LOOP CUTTER AND CONTINUED THE PROCEDURE. THE ACTUAL PRODUCT ACCORDING TO THE REPORTER WAS REPLACED WITH A SIMILAR DEVICE AND THE INTENDED PROCEDURE (THERAPEUTIC ENDOSCOPIC POLYPECTOMY) WAS COMPLETED WITH NO HEALTH HAZARD TO THE PATIENT. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733168 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 1YK 04953170194641

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female PLIERS, LOOP CUTTERENDOSCOPE.