BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1130763 · Received August 5, 2008

    Report

    Report Number
    2020550-2008-00017
    Event Type
    Other
    Date Received
    August 5, 2008
    Date of Event
    February 11, 2008
    Report Date
    August 1, 2008
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED, DR WAS PERFORMING A CYSTOSCOPY PROCEDURE, WHEN ALLEGEDLY SOMEONE IN THE OR ACCIDENTALLY ACTIVATED THE FOOTPEDAL CAUSING DAMAGE TO THE INSTRUMENTS AND A SLIGHT BURN ON PT'S BLADDER. APPARENTLY, THE ELECTRODE INSTRUMENT WAS NOT IN CONTACT WITH TISSUE WHEN PEDAL WAS ACTIVATED WHICH RESULTED IN THE CURRENT JUMPING FROM ELECTRODE TO THE SCOPE. NO MEDICAL ATTENTION WAS NECESSARY FOR THE BURN AND PROCEDURE WAS COMPLETED. PT CONDITION POST-OP WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ INNER SHEATH FED KARL STORZ GMBH & CO. KG 27050XA DM

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other