BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2442619 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00018
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    October 13, 2010
    Report Date
    October 15, 2010
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012: THIS MDR IS BEING FILED BASED ON RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR. THE FACILITY DID NOT RETAIN THE DEVICE FOR EVAL, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. INVESTIGATION OF THE LOT HISTORY RECORD DID NOT NOTE ANY ISSUES DURING THE MFG OF THIS LOT. DUE TO PREVIOUS COMPLAINTS OF SIMILAR OCCURRENCES, A CORRECTIVE ACTION REPORT (B)(4) HAS BEEN OPENED TO FURTHER INVESTIGATE THIS TYPE OF FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ADENOID TIP BROKE SEPARATED ABOVE THE GREY CONNECTOR. THERE WAS NO IMPACT TO THE PT, AND NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. PLASMABLADE TNA 30517

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE