BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2442653 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00007
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER. VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THE ENAMEL COATING OF THE ELECTRODE BLADE CAME LOOSE. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO HANDLING TECHNIQUE DURING USE, THE ELECTRODE BLADE MAY HAVE BEEN FLEXED OR BENT EXCESSIVELY RESULTING IN THE ENAMEL COATING COMING LOOSE. A REVIEW OF THE LOT HISTORY RECORD (LHR) FOR THIS LOT NUMBER FOUND THAT THE DEVICE MET ASSEMBLY AND PRODUCT SPECIFICATIONS, NO ANOMALIES WERE FOUND DURING MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE, THE ENAMEL COATING TOWARD THE MIDDLE OF THE ELECTRODE BLADE WAS LIFTING OFF; THE PROCEDURE WAS COMPLETED WITHOUT ANY IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. PLASMABLADE 3.0S 32786

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE