BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2442618 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00015
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR. THE DEVICE WAS NOT RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNK THEREFORE; A REVIEW OF THE MFG DOCUMENTATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE ADENOID TIP BROKE OFF FROM THE GREY HUB. NO IMPACT TO PT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE