BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI INTRACORPOREAL ELECTROHYDRAULIC LITHOTRIPTOR (AN OLYMPUS COMPANY)

    MDR report key: 1603784 · Received February 5, 2010

    Report

    Report Number
    MW5014702
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 5, 2010
    Manufacturer
    GYRUS ACMI
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN OPERATING ROOM FOR CYSTOSCOPY AND REMOVAL OF BLADDER STONE VIA ELECTROHYDRAULIC LITHOTRIPTOR. DURING PROCEDURE WITH THE CYSTOSCOPE IN THE BLADDER, AN ACMI PROBE WAS INSERTED INTO THE CHANNEL BUT THE PHYSICIAN COULD NOT GENERATE ANY HYDROELECTRIC SHOCK FROM THE DEVICE. A SECOND PROBE WAS TRIED BUT THAT WOULD NOT WORK EITHER. THE PROCEDURE WAS TERMINATED. THE PT WILL BE SCHEDULED TO RETURN TO THE OPERATING ROOM FOR A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AT A LATER DATE. AT THAT TIME, THE STONE WILL BE REMOVED. PRELIMINARY EVAL OF THE DEVICE BY VENDOR INDICATED MALFUNCTION OF CONNECTOR CABLE. DEVICE WAS ON LOAN AND WILL BE RETURNED TO THE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS ACMI INTRACORPOREAL ELECTROHYDRAULIC LITHOTRIPTOR (AN OLYMPUS COMPANY) ELECTROHYDRAULIC LITHOTRIPTOR FFK GYRUS ACMI AEH - 4
    2 GYRUS ACMI 9 FR ELECTROHYDRAULIC LITHOTRIPTOR PROBE ACMI EXTENDER CABLE AEH EC FFK GYRUS ACMI AEH 4 EC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR