BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CONNECTING CABLE

    MDR report key: 534707 · Received January 9, 2004

    Report

    Report Number
    1418479-2003-00043
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Date of Event
    November 20, 2003
    Report Date
    December 12, 2003
    Manufacturer
    BOWA ELECTRONIC GMBH
    Product Code
    IKD
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A MONOPOLAR ELECTRO-SURGICAL CABLE WAS BEING CHECKED FOR USE DURING A LAPAROSCOPY CASE. WHEN POWER WAS APPLIED, THE CABLE SPARKED. ANOTHER CABLE WAS OBTAINED AND THE CASE WAS COMPLETED WITH NO INJURIES BEING REPORTED. THE CABLE WAS SUBSEQUENTLY DISCARDED FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CONNECTING CABLE NONOPOLAR CONNECTING CABLE IKD BOWA ELECTRONIC GMBH 8106.033 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *