BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 2935676 · Received January 30, 2013

    Report

    Report Number
    3005075853-2013-00394
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). HANDLE DEVICE A WAS RECEIVED WITH THE HANDLE BROKEN. THE INSTRUMENT WAS ATTACHED TO AN HANDPIECE AND TESTED WITH THE HANDLE BROKEN. THERE WAS SOME DIFFICULTY ATTACHING BUT THE INTENT WAS TO TEST THE INSTRUMENT AS MUCH AS POSSIBLE. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FOUND TO ACTIVATE. IT WAS NOT POSSIBLE TO TEST THE JAW FUNCTION DUE TO THE BROKEN HANDLE. THE BLADE WAS FOUND IN GOOD CONDITIONS. IT IS POSSIBLE THAT THE HANDLE BROKE IF IT WAS USED TO TORQUE THE INSTRUMENT ON OR OFF THE HANDPIECE. IT IS RECOMMENDED THAT THE PROVIDED TORQUE WRENCH BE USED WHEN ATTACHING THE INSTRUMENT TO A HANDPIECE. DEVICE B WAS RETURNED IN GOOD VISUAL CONDITIONS. THE DEVICE WAS ATTACHED TO THE HANDPIECE AND IT WAS NOTED THAT THE BLADE WAS LOOSE. THE INSTRUMENT WAS DISASSEMBLED AND IT WAS FOUND TO HAVE THERMAL DAMAGE AT THE SHROUDS AND INSULATED PIN INTERFACE. HEAT WAS GENERATED AT THIS INTERFACE RESULTING IN THE MELTING OF THE SHROUDS. THIS ALLOWED THE BLADE NOT TO BE HELD FIRMLY BY THE TWO SHROUDS. BECAUSE OF THIS BLADE CONDITION THE BLADE WAS LOOSE AND WAS WE WERE NOT ABLE TO ATTACH IT TO A HAND PIECE AND TEST IT FULLY. THIS DAMAGE COULD HAVE RESULTED FROM NOT TORQUING THE INSTRUMENT PROPERLY TO THE HAND PIECE; RESULTING IN EXCESSIVE HEAT GENERATION AT THE INSULATED PIN. DEVICE B BATCH J91R04, MFG DATE 7-13-2012, EXP DATE 6-13-2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TUMOR 'DEBULKING' PROCEDURE, THE HANDLE OF THE INSTRUMENT ACCIDENTALLY BROKE SO THE DOCTOR REQUESTED FOR ANOTHER ONE, BUT IT AGAIN BROKE WHILE HE WAS USING IT, PART OF ITS TIP /CLIPPER WAS ALSO BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41294 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J4AZ5V

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE