BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE SHEARS 5.5 DIAM.

    MDR report key: 2071347 · Received April 21, 2011

    Report

    Report Number
    MW5020365
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR (B)(4) 2011: WE HAVE BEEN INFORMED THAT OUR HARMONIC (B)(4) WAS REPROCESSED BY ASCENT AND USED IN AN UNK PROCEDURE ON (B)(6) 2011, AT (B)(6) HOSPITAL CENTER IN (B)(6). THE COMPLAINT WAS THAT THE DEVICE FUNCTIONED FOR ABOUT 30 MINS AND THEN STOPPED WORKING. OUR INSTRUCTIONAL INSERT STATES IN DEVICE DESCRIPTION THAT THE HARMONIC ACE IS A STERILE, SINGLE PT USE INSTRUMENT¿" AND UNDER WARNINGS AND PRECAUTIONS, "THIS DEVICE IS PACKAGED AND STERILIZED FOR SINGLE USE ONLY. DO NOT REUSE, REPROCESS OR RESTERILIZE. REUSE, REPROCESSING, OR RESTERILIZATION MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE AND/OR LEAD TO DEVICE FAILURE THAT IN TURN MAY RESULT IN PT INJURY, ILLNESS OR DEATH. CLEANING AND RESTERILIZATION OF SINGLE PT USE HARMONIC DEVICES CAN ALSO RESULT IN ABNORMALLY HIGH SHEATH TEMPERATURES AND BURN INJURY TO USER OR PT WHEN THE BLADE IS ACTIVATED. ALSO, REPROCESSING OR RESTERILIZATION OF SINGLE USE DEVICES MAY CREATE A RISK OF CONTAMINATION AND/OR CAUSE PT INFECTION OR CROSS-INFECTION, INCLUDING, BUT NOT LIMITED TO, THE TRANSMISSION OF INFECTIOUS DISEASE(S) FROM ONE PT TO ANOTHER. CONTAMINATION OF THE DEVICE MAY LEAD TO INJURY, ILLNESS, OR DEATH OF THE PT. RESPONSIBILITY FOR ANALYZING THIS DEVICE BELONGS TO THE REPROCESSING COMPANY ASCENT. (B)(4).

    Description of Event or Problem · 1

    REPROCESSED HARMONIC ACE SCALPEL WAS OPENED, CONNECTED AND TESTED PRIOR TO PROCEDURE. THE HANDPIECE FUNCTIONED FOR ABOUT 30 MIN., THEN STOPPED WORKING. NEW DEVICE WAS OPENED AND CASE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE SHEARS 5.5 DIAM. NONE LFL ETHICON ENDO-SURGERY, INC. ACE 36E 1470958

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention