BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1880934 · Received October 25, 2010

    Report

    Report Number
    3005075853-2010-06027
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND FUNCTIONAL TESTING WAS PERFORMED. DURING FUNCTIONAL TESTING, THE CLAMP ARM OPENED AND CLOSED PROPERLY ¿ THERE WERE NO ISSUES WERE NOTED WITH THE CLAMP ARM. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC THYROIDECTOMY PROCEDURE, THE DOCTOR ACTIVATED THE INSTRUMENT. AFTER THE DOCTOR PUT AN ARTERY BETWEEN THE JAWS, CLOSED THE JAWS AND ACTIVATED IT, THE JAW WAS NOT OPEN. THE DOCTOR OPENED THE JAW FORCIBLY WITH EXCESSIVE POWER AND TRIED WITH ANOTHER TISSUE, THE JAW DID NOT OPEN REPEATEDLY. IT LOOKED LIKE THE JOINT OF THE BLADE AND TEFLON HAD SOME PROBLEM AND IT DID NOT OPEN. HE USED ANOTHER DEVICE AND THE CASE WAS DONE WELL. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE