BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 2231250 · Received July 25, 2011

    Report

    Report Number
    2648666-2011-00175
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE DEVICE WAS FAULTY. IT WAS FURTHER REPORTED THAT THE SURGEON USED ANOTHER DEVICE TO FINISH THE SURGERY. FURTHER, THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE SUCTION PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 11034AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK