BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)

    MDR report key: 12493166 · Received September 18, 2021

    Report

    Report Number
    8010047-2021-11938
    Event Type
    Malfunction
    Date Received
    September 18, 2021
    Date of Event
    June 22, 2021
    Report Date
    September 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170399329
    PMA / PMN Number
    K141991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION OF OMSC THE FOLLOWING WAS CONFIRMED, THE LOT NUMBER WAS 0YV WITH SUPPLEMENTARY INFORMATION NUMBER OF "09". THE CUTTING WIRE WAS BROKEN. THE BROKEN PORTION WAS SCORCHED AND MELTED. THE OUTER DIAMETER OF THE CUTTING WIRE WAS MEASURED. THE RESULT INDICATED NO ABNORMALITIES. THE LENGTH OF THE COATED PORTION OF THE CUTTING WIRE, AND THE CUTTING WIRE ITSELF PRESENTED NO ABNORMALITIES. THERE WERE NO MISSING PARTS IN THE SUBJECT DEVICE. NO OTHER ABNORMALITIES WERE CONFIRMED EXCEPT THE BREAKAGE OF THE CUTTING WIRE. NO ABNORMALITIES WERE DETECTED IN THE DEVICE HISTORY RECORD WITH THE LOT NUMBER FOR THE FOLLOWING INSPECTION ITEMS WHICH RELATED TO THE REPORTED PHENOMENON. LENGTH OF CUTTING WIRE. LENGTH OF COATED PORTION. OPERATION OF CUTTING WIRE. BASED ON THE CONFIRMATION RESULT, IT CAN BE DETERMINED THAT THE CUTTING WIRE WAS BROKEN WHILE THE OUTPUT WAS ACTIVATED. BASED ON THE CONFIRMATION RESULT AND THE INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE BROKEN CUTTING WIRE MIGHT BE THE FOLLOWING. THE DEVICE WAS NOT PROTRUDED ENOUGH FROM THE ENDOSCOPE UNTIL THE REAR END OF THE CUTTING WIRE WAS IN THE FIELD OF VIEW. DUE TO THE SITUATION OF "1" DESCRIPTION, THE CUTTING WIRE AND THE ENDOSCOPE WERE BEING CLOSE TO EACH OTHER. THE OUTPUT WAS ACTIVATED IN STATE OF "2" DESCRIPTION. THIS MIGHT HAVE LED TO AN ELECTRICAL DISCHARGE BETWEEN THE CUTTING WIRE AND THE DISTAL END OF THE ENDOSCOPE. AN ELECTRICAL DISCHARGE POSSIBLY OCCURRED, AND THE CUTTING WIRE BECAME HOT INSTANTLY. THAT MIGHT HAVE CAUSED THE CUTTING WIRE TO BREAK. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE CUTTING WIRE BROKE BEFORE THE END OF THE SPHINCTEROTOMY DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE OMSC CONFIRMED THE FOLLOWING EVENT ON (B)(6) 2021 AND DETERMINED THAT IT WAS AN MEDICAL DEVICE REPORT (MDR) REPORTABLE EVENT. THE KNIFE WIRE WAS BROKEN WITH ENERGIZATION. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390780 SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) SINGLE USE PRELOADED SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-VC411Q-0730 0YV 04953170399329

    Patients

    Seq Age Sex Outcome Treatment
    1