BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR CABLE

    MDR report key: 4092754 · Received September 10, 2014

    Report

    Report Number
    9610617-2014-00034
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FAS
    PMA / PMN Number
    K061541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIPOLAR CABLE WAS RETURNED AND CONDITION NOTED; DAMAGED AND MATERIAL MELTED; IT WILL BE SENT TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMING A TURP WHEN HE NOTED THAT THE PATIENT "BUCKED" AS IF SHOCKED. HE REMOVED THE INSTRUMENTATION AND FOUND THAT THE CONNECTOR ON THE BIPOLAR CABLE HAD BECOME DAMAGED AND SOME OF THE MATERIAL APPEARED MELTED; PART OF THE PROXIMAL END OF THE ELECTRODE WAS FUSED WITH THE CABLE. THE DOCTOR REPLACED THE CABLE AND THE ELECTRODE AND WENT ON TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT; PATIENT CONDITION POST-OP WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556827 BIPOLAR CABLE BIPOLAR CABLE FAS KARL STORZ GMBH & CO. KG 27176LEB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention