BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM-90S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 1812886 · Received August 16, 2010

    Report

    Report Number
    2648666-2010-00356
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD TORN OR DAMAGED INSULATION AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM-90S MAX SERFAS ENERGY SUCTION PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 10162AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK