BEUDAMED
    FDA Adverse Event Summary report: N

    ETHICON ENDO-SURGERY INC

    MDR report key: 3035163 · Received March 29, 2013

    Report

    Report Number
    MW5029586
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ETHICON ENDO-SURGERY INC.
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE: ACE 36 E HARMONIC SCALPEL INSTRUMENT WAS USED. IT IS A DISPOSABLE INSTRUMENT ETHICON HARMONIC ACE SHEARS, 5.5 DIAMETER ERG. HANDLE, CURVE BLADE 36CM. PHYSICIAN REPORTED THAT THE HARMONIC SCALPEL WAS NOT WORKING CORRECTLY. IT WAS REPLACED IMMEDIATELY WITH A NEW REPROCESSED HANDPIECE AND IT WORKED PROPERLY. PHYSICIAN(S) FELT THAT THE INSTRUMENT CAUSED EXTRA BLEEDING AT THE SPLEEN AND STOMACH WHICH DELAYED THE CASE AND AFFECTED THE FLOW OF THE OPERATION. TOTAL EBL WAS 50CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130095 ETHICON ENDO-SURGERY INC HARMONIC ACE SHEARS NLQ ETHICON ENDO-SURGERY INC. ACE36E 2321257

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR