BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL FOOTSWITCH

    MDR report key: 563071 · Received May 20, 2004

    Report

    Report Number
    1527736-2004-01463
    Event Type
    Malfunction
    Date Received
    May 20, 2004
    Date of Event
    February 26, 2004
    Report Date
    May 18, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MIN AND MAX ON THE FOOTSWITCH WOULD CUT OUT INTERMITTENTLY DURING A SPINAL IMPLANT. THE CASE WAS COMPLETED WITH THE FOOTSWITCH WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL FOOTSWITCH ULTRACISION SURGERY REUSABLE DEVICES, FOOTSWITCH LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other