BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    MDR report key: 2772391 · Received October 4, 2012

    Report

    Report Number
    3005075853-2012-04535
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE HANDPIECE WAS RECEIVED IN GOOD PHYSICAL CONDITION. IT WAS CONNECTED TO A GENERATOR, EVALUATED WITH A TEST INSTRUMENT AND AN ERROR CODE 7 WAS DISPLAYED BY THE SCREEN WHEN TRYING TO PERFORM THE HAND ACTIVATION TEST. THE INSTRUMENT WAS DISASSEMBLED TO PERFORM AN INTERNAL ELECTRICAL TEST THAT REVEALED A SHORT CIRCUIT CONDITION AT THE CABLE LEVEL, AFFECTING THE HAND ACTIVATION FEATURE OF THE DEVICE IN SUCH WAY THAT MADE IT NOT FUNCTIONAL. NO CONCLUSION COULD BE DRAWN AS TO WHAT CAUSED THIS CABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HAND SWITCH WAS BROKEN. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION** HARMONIC SCALPEL** HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR