BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1882607 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06072
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION THE DEVICE WAS RETURNED WITH THE TISSUE PAD MELTED AND PARTIALLY DETACHED. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM; AND ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. BOTH CONDITIONS CAN RESULT IN PROBABLE DAMAGE TO THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC GYN PROCEDURE, THE TISSUE PAD FELL OFF OF DEVICE AND INTO THE PATIENT. THE TISSUE PAD WAS RETRIEVED LAPAROSCOPICALLY WITHOUT HARM TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AT TRYING TO PUT THE CLIP ON THE CYSTIC, THE CLIP KEPT ALMOST OPEN ON THE CYSTIC. THEY HAD TO REMOVE THE CLIP VERY CAREFULLY TO AVOID INJURING THE CYSTIC. ANOTHER 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 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1