BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 10487508 · Received September 3, 2020

    Report

    Report Number
    10487508
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 19, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THE HANDPIECE OF THE ETHICON ENDO-SURGERY, LLC HARMONIC ACE HAR36 HAD A VERY SMALL PIECE BREAK OFF. THE PIECE WAS RETRIEVED AND TAPE TO THE HANDPIECE AND REMOVED FROM THE FIELD. MANUFACTURER RESPONSE FOR HARMONIC ACE SHEAR, HARMONIC HAR36 (PER SITE REPORTER) MANUFACTURER PROVIDED RGA NUMBER AND PRODUCT RETURN PACKAGING.

    Description of Event or Problem · 1

    THE HANDPIECE OF THE ETHICON ENDO-SURGERY, LLC HARMONIC ACE HAR36 HAD A VERY SMALL PIECE BREAK OFF. THE PIECE WAS RETRIEVED AND TAPE TO THE HANDPIECE AND REMOVED FROM THE FIELD. MANUFACTURER RESPONSE FOR HARMONIC ACE SHEAR, HARMONIC HAR36 (PER SITE REPORTER). MANUFACTURER PROVIDED RGA NUMBER AND PRODUCT RETURN PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952323 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC HAR36 U93M7F

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA