BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 2251630 · Received August 30, 2011

    Report

    Report Number
    2648666-2011-00211
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 5, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 A SURGICAL PROCEDURE, THE SURGEON NOTICED THAT THE TIP OF THE UNIT WAS MISSING. IT WAS FURTHER REPORTED THAT THE SURGEON LOCATED THE 2 BROKEN PIECES OF THE TIP AND REMOVED THEM FROM THE PT. AN X-RAY WAS TAKEN AND NO FOREIGN OBJECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90-S SERFAS ENERGY SUCTION PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 11077AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK