BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23CM W ERG HANDLE

    MDR report key: 1890959 · Received November 4, 2010

    Report

    Report Number
    3005075853-2010-06291
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION RECEIVED THAT THE TISSUE PAD WAS MELTED - FILE DOES NOT MEET THE REQUIREMENTS OF A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION RECEIVED THAT THE TISSUE PAD WAS MELTED - FILE DOES NOT MEET THE REQUIREMENTS OF A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE TISSUE PAD MELTED AND FELL APART (RETURN IN SPECIMEN BOTTLE). ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE