BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS

    MDR report key: 2850025 · Received November 26, 2012

    Report

    Report Number
    2850025
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    TIP OF THE DEVICE BROKE OFF WHILE IN USE. PATIENT NEEDED TO BE SEARCHED. DEVICE FOUND AND SAFELY REMOVED. DEVICE WAS A DISPOSABLE ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE CURVED SHEARS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES LFL ETHICON ENDO-SURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR