BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS

    MDR report key: 1852529 · Received October 4, 2010

    Report

    Report Number
    3005075853-2010-05676
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE TEFLON PAD FELL OFF AND WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER LIKE 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 ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK G4T04M

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE