BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90 DEGREE SERFAS ENERGY PROBE

    MDR report key: 2221412 · Received August 16, 2011

    Report

    Report Number
    2648666-2011-00195
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE ON THE RIGHT SHOULDER, THE TIP OF THE UNIT BROKE OFF INTO THE PT. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS EXTRACTED FROM THE PT. THE PROCEDURE WAS DELAYED ABOUT ONE MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90 DEGREE SERFAS ENERGY PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 11049AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK