BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 2251542 · Received August 9, 2011

    Report

    Report Number
    2648666-2011-00186
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING "A CASE THE CLEADING ON THE TIP OF THE DEVICE WAS DEFORMED AND LOOSE." IT WAS FURTHER REPORTED THAT A REPLACEMENT DEVICE WAS AVAILABLE AND THE CASE WAS COMPLETED WITHOUT DELAY.

    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 11081AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK