BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    MDR report key: 2922824 · Received January 18, 2013

    Report

    Report Number
    3005075853-2013-00280
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 11, 2012
    Report Date
    November 12, 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
    FR
    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 MID-HOUSING 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 DEVICE DOES NOT ACTIVATE. IN (B)(4) TESTED THE DEVICE PROCEDURE "71 PM 170 ZR 36." ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27999 ULTRACISION** HARMONIC SCALPEL** HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR