BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMAND II OSCILLATING SAW

    MDR report key: 255120 · Received December 17, 1999

    Report

    Report Number
    1811755-1999-00029
    Event Type
    Injury
    Date Received
    December 17, 1999
    Date of Event
    October 22, 1999
    Report Date
    December 16, 1999
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING OPERATION, THE SURGEON WAS USING OSCILLATING HANDPIECE WITH FIVE MINUTE INTERVALS. THE PT WAS BURNED ON THE UNDERSIDE OF THE LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMAND II OSCILLATING SAW SAW, BONE, AC-POWERED DZH STRYKER INSTRUMENTS 2296-031-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention