BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGITOOL

    MDR report key: 2113475 · Received May 25, 2011

    Report

    Report Number
    1831750-2011-05069
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ROLL PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SURGISTOOL BRAKES WOULD NOT LOCK. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL 0830 NA

    Patients

    Seq Age Sex Outcome Treatment
    1