BEUDAMED
    FDA Adverse Event Other Summary report: N

    HANDLE F/MONOPOLAR ELECTRODES 5MM

    MDR report key: 725960 · Received May 31, 2006

    Report

    Report Number
    2916714-2006-00029
    Event Type
    Other
    Date Received
    May 31, 2006
    Date of Event
    April 19, 2006
    Report Date
    May 30, 2006
    Manufacturer
    AESCULAP, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, ITEM WILL BE FORWARDED TO MANUFACTURER FOR ANALYSIS, AESCULAP, GERMANY.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, ARCING OCCURRED DUE TO A DAMAGED CERAMIC TIP ON THE MONOPOLAR HANDLE, WHICH EXPOSED THE INNER METAL SHAFT. THE PATIENT RECEIVED A BURN TO THE LIVER. SEVERAL ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION. REFERENCE: 2916714-2006-00030 DEVICE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDLE F/MONOPOLAR ELECTRODES 5MM ACCESSORIES FOR COAGULATION GEI AESCULAP, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN