BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC TRUETOME 44-30MM CUT WIRE 4.4F X 30MM

    MDR report key: 21633966 · Received March 18, 2025

    Report

    Report Number
    MW5167766
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    March 12, 2025
    Report Date
    March 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NLR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERGOING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY). EQUIPMENT MALFUNCTION INTRAOPERATIVELY. EQUIPMENT WAS SWITCHED OUT. NO HARM TO THE PATIENT. TRUETOME 44 30MM CUTE WIRE DID NOT TRIGGER TO CUT DURING PROCEDURE WHEN HOOKED UP TO ERBE MACHINE. NEW ERBE MACHINE WAS BROUGHT INTO PROCEDURE ROOM, TOME WAS PLUGGED IN AND STILL DID NOT FIRE. BOSTON SCIENTIFIC REP STATED IT COULD HAVE POSSIBLY BEEN THE TOME WE WERE USING, SO WE IMMEDIATELY REMOVED FROM PATIENT, SWAPPED IT OUT FOR A NEW TOME AND IT SUCCESSFULLY FIRED. BOSTON SCIENTIFIC TRUETOME 44-30MM CUT WIRE 4.4F X 30MM, GTIN: (B)(4), REF: M00584180, LOT: 34902720.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211756 BOSTON SCIENTIFIC TRUETOME 44-30MM CUT WIRE 4.4F X 30MM UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) NLR BOSTON SCIENTIFIC CORPORATION M00584180 34902720

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female