BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL

    MDR report key: 2052950 · Received April 8, 2011

    Report

    Report Number
    MW5020221
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ETHICON
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HARMONIC SCALPEL IN USE WAS MALFUNCTIONING. THEREFORE, THE DISPOSABLE HANDPIECE WAS REPLACED AND THE SURGICAL PROCEDURE CONTINUED. THE SCRUB NURSE OBSERVED THAT PART OF ONE OF THE TIPS OF THE MALFUNCTIONING HARMONIC SCALPEL HANDPIECE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL HARMONIC SCALPEL LFL ETHICON H9083V

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR