BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2442652 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00006
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    August 19, 2010
    Report Date
    August 20, 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 A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER. VISUAL EXAMINATION OF THE RETURNED RECORD (LHR) FOR THIS LOT NUMBER FOUND THAT THE DEVICE MET ASSEMBLY AND PRODUCT SPECIFICATIONS, NO ANOMALIES WERE FOUND DURING MANUFACTURING. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT DURING REMOVAL OF THE TIP FROM THE FINGER GRIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADENOID TIP BROKE OFF AT THE BASE. THERE WAS NO 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 TNA 30115

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE