BEUDAMED
    FDA Adverse Event Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 1032503 · Received April 16, 2008

    Report

    Report Number
    2648666-2008-00044
    Date Received
    April 16, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    TIP BROKE OFF IN PT SHOULDER. CASE WAS DELAYED ONE HOUR IN ORDER TO REMOVE THE TIP. THE CASE WAS COMPLETED.

    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 08010AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK