BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 1735359 · Received June 15, 2010

    Report

    Report Number
    1831750-2010-01223
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    FZM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGISTOOL DOES NOT GO UP OR DOWN AND HAD AN OIL LEAK. NO ADVERSE CONSEQUENCES WERE ALLEGED.

    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