BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    MDR report key: 2911122 · Received January 11, 2013

    Report

    Report Number
    3005075853-2013-00198
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    August 22, 2012
    Report Date
    August 22, 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
    KS
    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. THE INSTRUMENT WAS DISASSEMBLED TO PERFORM AN INTERNAL ELECTRICAL TEST THAT REVEALED AN SHORT CIRCUIT CONDITION AT THE CABLE LEVEL, AFFECTING THE HAND PIECE 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 INSTRUMENTS COULDN'T BE WORKED WELL WITH THESE HANDPIECES REGARDLESS OF CHANGING INSTRUMENTS. NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17417 ULTRACISION** HARMONIC SCALPEL** HAND PIECE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR