BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE HARMONIC SCALPEL

    MDR report key: 1840202 · Received September 16, 2010

    Report

    Report Number
    MW5017458
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    STERILMED
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPROCESSED HARMONIC SCALPEL FAILED DURING SURGICAL PROCEDURE. NO HARM TO THE PT. STERILEMED ACE HARMONIC SCALPEL ACE36E (B)(4) DEVICE (B)(4) EXP 720/2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE HARMONIC SCALPEL SCALPEL NLQ STERILMED

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR