BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 2465597 · Received February 16, 2012

    Report

    Report Number
    MW5024304
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    November 28, 2011
    Report Date
    February 16, 2012
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A LAPAROSCOPIC TOTAL HYSTERECTOMY, EXAMINATION UNDER ANESTHESIA, RIGID CYSTOSCOPY AND LEFT OVARIAN CYST DRAINAGE. HARMONIC CURVED SHEARS KEPT TRIPPING AND BEING RESET. CHANGED THE CORD WHICH HELPED A LITTLE. SWITCHED OUR DISPOSABLE UNIT AND HAD NO FURTHER TROUBLE. DELAY SURGERY BY APPROX 20 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, LLC HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE, 36MM LFL ETHICON ENDO-SURGERY ACE36E H91V3K

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Disability