BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE SHEARS, ERG HANDLE, CURVED BLADE

    MDR report key: 3074582 · Received April 18, 2013

    Report

    Report Number
    MW5029871
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ETHICON ENDO-SURGICAL, INC.
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHITE TIP OF FIRST (#1) REPROCESSED HARMONIC ACE SHEARS REPLACED WITH IDENTICAL UNIT (#2) WITH THE SAME LOT NUMBER AFTER PEELING OF WHITE TIP NOTED. THE SECOND DEVICE (#2) THEN ALSO BEGAN PEELING WITHIN TWO MINS OF USE. A SUBSEQUENT IDENTICAL UNIT (#3) WITH THE SAME LOT NUMBER WAS REPORTED BY THE STAFF TO HAVE BEEN USED TO COMPLETE THE PROCEDURE W/O INCIDENT. REASON FOR USE: LAPAROSCOPIC HYSTERECTOMY, BSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168246 HARMONIC ACE SHEARS, ERG HANDLE, CURVED BLADE HARMONIC SCALPEL, 5.5 DIA, 36 CM NLQ ETHICON ENDO-SURGICAL, INC. ACE36E 2405895
    168247 HARMONIC ACE SHEARS, ERG HANDLE, CURVED BLADE HARMONIC SCALPEL, 5.5 DIA, 36 CM NLQ ETHICON ENDO-SURGICAL, INC. ACE36E *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR