BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    88-000006 ROCKER W/COATED BLADE N/S

    MDR report key: 308559 · Received December 8, 2000

    Report

    Report Number
    1046367-2000-00030
    Event Type
    Malfunction
    Date Received
    December 8, 2000
    Date of Event
    October 13, 2000
    Report Date
    December 8, 2000
    Manufacturer
    DEROYAL
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE "ON" SWITCH REMAINS ACTIVATED WHEN NOT DEPRESSED. THE FAILURE WAS DETECTED IMMEDIATELY AND THERE WAS NO IMPACT TO THE PT. THE DEVICE WAS REPLACED WITH ANOTHER DEROYAL PENCIL AND THE SURGERY PROCEEDED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 88-000006 ROCKER W/COATED BLADE N/S 7E1 CAUTERY PENCIL GEI DEROYAL 06 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other