BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SYNERGY* DISSECTING HOOK

    MDR report key: 1870040 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05876
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 5, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K012176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THERMAL DAMAGE. THE DEVICE WAS RECEIVED WITH THE SHEATH OFF THE SHROUDS ASSEMBLY. THE DEVICE COULD NOT BE TESTED DUE TO THE INTERNAL DAMAGE OF THE INSTRUMENT. THE INSTRUMENT WAS VISUALLY INSPECTED AND THERMAL DAMAGE AT THE SHROUDS AND INSULATED PIN INTERFACE WERE FOUND. THIS DAMAGE COULD HAVE RESULTED FROM NOT TORQUING THE INSTRUMENT PROPERLY TO THE HAND PIECE; RESULTING IN EXCESSIVE HEAT GENERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SYNERGY BLADE AND PLASTIC HANDGRIP GOT EXTREMELY HOT. THIS CAUSED IT TO MELT. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED POST IMPLANT A REALIZE ADJUSTABLE BAND, DURING A FILL, THE SURGEON TRIED TO ASPIRATE FLUID BUT COULD NOT. A CT SCAN WAS PERFORMED AND THE TUBING APPEARS TO BE DISCONNECTED FROM THE PORT. THE PATIENT HAS A FOLLOW UP APPOINTMENT TO DISCUSS RECONNECTING THE TUBING. THE SURGEON PLANS TO EXPLANT THE ORIGINAL PORT AND PUT IN A NEW PORT. THE DEVICE IS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SYNERGY* DISSECTING HOOK INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENEATOR AND HANDPIECE