BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 4182362 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07204
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    April 28, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. BATCH THE DEVICE WAS RECEIVED WITH THE HAND ACTIVATIONS CONTACTS BENT. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE WITH DIFFICULTY. DURING MECHANICAL TESTING, THE ROTATION KNOB DID NOT ROTATE FREELY. THE DEVICE WAS THEN FUNCTIONALLY TESTED ON THE GEN11 GENERATOR. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. THE DAMAGED HAND ACTIVATION CONTACTS COULD CAUSE ROTATIONAL ISSUES WITH THE DEVICE. IN ADDITION, IT CAN CAUSE IMPROPER TORQUING OF THE BLADE, WHICH COULD CAUSE THE GENERATOR TO DISPLAY COMMUNICATION OR ACTIVATION ISSUES AND ALERT SCREENS. TO AVOID DAMAGING THE CONTACTS, IT IS RECOMMENDED TO ASSEMBLE THE DEVICE VERTICALLY. HAND SWITCH CONTACTS DAMAGED DUE TO TILTED HANDPIECE HITTING CONTACT TOP SURFACE DURING ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SHAFT WAS VERY DIFFICULT TO ROTATE. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH THE SAME DEVICE. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662040 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE