BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CONNECTING CABLE

    MDR report key: 533513 · Received March 12, 2004

    Report

    Report Number
    1418479-2004-00006
    Event Type
    Malfunction
    Date Received
    March 12, 2004
    Date of Event
    February 10, 2004
    Report Date
    February 13, 2004
    Manufacturer
    BOWA ELECTRONICS GMBH
    Product Code
    IKD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MONOPOLAR ELECTRO-SURGICAL CABLE WAS IN USE DURING A LAPAROSCOPIC CHOLECYSTECTOMY CASE. WHEN POWER WAS APPLIED, THE CABLE BURNED IN TWO NEAR THE END THAT CONNECTED TO THE GENERATOR. ANOTHER CABLE WAS SUBSTITUTED IMMEDIATELY TO COMPLETE THE CASE. NO INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN