BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEAK SURGICAL

    MDR report key: 1993104 · Received February 10, 2011

    Report

    Report Number
    MW5019404
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 10, 2011
    Manufacturer
    PEAK SURGICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE PEAK BLADE SYSTEM DEVICE CAME OFF DURING ADENOIDECTOMY. IF FELL OFF INTO THE PT'S MOUTH. THE POWER SHUT OFF AS THE PART FELL OFF. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK SURGICAL PEAK PLASMA BLADE GEI PEAK SURGICAL 31426

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Disability