BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 1974629 · Received December 29, 2010

    Report

    Report Number
    1831750-2010-05294
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DIVISION
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SURGISTOOL WOULD NOT RAISE UP WHEN PEDAL IS PUMPED AND LEAKAGE DETECTED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA