BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 1203182 · Received October 10, 2008

    Report

    Report Number
    2648666-2008-00115
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 1, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED, AFTER INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    NURSE REPORTED TO OUR SALES REP, THAT SHE WAS OBSERVING A SURGERY PROCEDURE. DURING THIS PROCEDURE, SHE OBSERVED THAT THE SURGEON HAD PROBLEMS WITH THE PROBE. THE SURGEON NOTICED THAT THE TIP OF THE PROBE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 08077AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK