BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3042133 · Received April 4, 2013

    Report

    Report Number
    3042133
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STERILMED, INC
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    REPROCESSED HARMONIC SCALPEL MALFUNCTIONED DURING SURGICAL PROCEDURE. TIP OF INSTRUMENT APPEARS TO BE WORN OUT AT WHITE AREA WITH METAL SHOWING THROUGH. DEVICE REMOVED FROM SURGICAL FIELD AND REPLACED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC GASTRIC BYPASS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138936 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL NLQ STERILMED, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR