BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 80105 · Received March 24, 1997

    Report

    Report Number
    2916288-1997-00004
    Event Type
    Injury
    Date Received
    March 24, 1997
    Report Date
    March 24, 1997
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS THE PHYSICIAN WAS PREPARING TO USE A LAPROSCOPIC PROBE, INSULATION FAILURE OCCURRED AT THE INSTRUMENT END OF THE ITEM. USE OF THE ITEM IN THIS CONDITION RESULTED IN A PHYSICIAN BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN RESUABLE LAPROSCOPIC PROBE GCJ OLSEN ELECTROSURGICAL, INC. 1000 009886

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other