BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 1910887 · Received November 30, 2010

    Report

    Report Number
    1527736-2010-00113
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY USER FACILITY MEDWATCH (B)(4) THAT AFTER A COLOSTOMY REVERSAL PROCEDURE IN WHICH THE SURGEON WAS USING THE HARMONIC CURVED SHEARS, THE SHEARS WERE BEING CLEANED AND THE TIP BROKE. IT WAS NOT BEING USED ON THE PATIENT AT THE TIME OF THE INCIDENT AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WILL NOT BE RELEASED BUT IS AVAILABLE FOR ONSITE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE