BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SHEAR

    MDR report key: 1951098 · Received December 28, 2010

    Report

    Report Number
    MW5018833
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 28, 2010
    Manufacturer
    ETHICON HARMONIC SHEAR
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FAILURE DURING CASE: WHITE SHEAR COVER FELL OFF TIP -TAPED TO INSIDE OF PACKAGE- PROCEDURE: LPS SIGMOID COLECTOMY, PHYSICIAN: DR (B)(6). CLINICIAN: (B)(6). AWAITING RETURN CALL TO CONFIRM REPLACEMENT AND DISPOSITION INSTRUCTIONS. IS IT FEASIBLE TO HAVE ALL MANUFACTURERS MARK RETURN ADDRESS AND CONTACT NUMBERS FOR ALL PRODUCTS ON EXTERIOR PACKAGING TO FACILITATE QUALITY CONCERNS WITH CONSUMERS? (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SHEAR HARMONIC SHEAR ACE36E LFL ETHICON HARMONIC SHEAR G9LJ5R

    Patients

    Seq Age Sex Outcome Treatment
    1 *