BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEAK PLASMA BLADE 4.0

    MDR report key: 6092340 · Received November 8, 2016

    Report

    Report Number
    MW5065947
    Event Type
    Other
    Date Received
    November 8, 2016
    Manufacturer
    MEDTRONIC HEADQUARTERS
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECT DETERMINED IN TESTING - NEVER USED ON PATIENT. PEAK 4.0 PLASMA BLADE INTERMITTENTLY FUNCTIONING. SURGEON REPORTS THAT BLADE SPINS AROUND WHEN IT SHOULD NOT. MANUFACTURER: PLEASE NOTE THAT WE DO NOT SEND PRODUCTS TO THE MANUFACTURER, BUT YOU MAY ARRANGE FOR PICK-UP BY CALLING MY NUMBER BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739105 PEAK PLASMA BLADE 4.0 PEAK PLASMA BLADE 4.0 GEI MEDTRONIC HEADQUARTERS PS200-040 FL509299056

    Patients

    Seq Age Sex Outcome Treatment
    1