BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 1972316 · Received December 30, 2010

    Report

    Report Number
    1831750-2010-05415
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    STRYKER CORP., MED DIV
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE STOOL IS LEAKING IOL. 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., MED DIV 0830000000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA