BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3140264 · Received May 31, 2013

    Report

    Report Number
    3005075853-2013-02700
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION WITH THE BLADE TIP NOT BROKEN OFF AS REPORTED BY THE CUSTOMER. HOWEVER, THE TIP OF THE BLADE WAS FOUND CONCEALED INSIDE THE SHAFT OF THE DEVICE. UPON INSPECTION OF THE HAND ACTIVATION CONTACTS, THE THREADED SIDE OF THE BLADE WAS FOUND OUTSIDE ITS INTENDED POSITION, THEREFORE THE HANDPIECE COULD NOT BE ATTACHED TO THE DEVICE, AND NO FUNCTIONAL TESTING COULD BE PERFORMED. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND THE INSULATED PIN THAT HOLDS THE BLADE TO THE INNER OUTER TUBE SUBASSEMBLY WAS FOUND CORRODED AND BROKEN OFF. HOWEVER, THERE WERE NO MISSING PIECES OF THE INSULATED PIN. THE CORROSION IN THE PIN IS POSSIBLY CAUSED WHEN THE DEVICE WAS SOAKED FOR RE-USE; THE INTRODUCTION OF SALINE OR BLOOD GETTING UP INTO THE DEVICE DURING THE PROCEDURE, OR THE DEVICE BEING SOAKED FOR CLEANING BEFORE SHIPMENT FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE A NEW STERILE PROBE WAS OPENED AND WAS ABOUT TO INSTALLED ON THE HAND PIECE BUT THE SHAFT AND THE BLADE SEPARATED. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242036 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE