BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 1034068 · Received April 24, 2008

    Report

    Report Number
    2648666-2008-00052
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT CERAMIC BROKE. CERAMIC AND ELECTRODE BROKE OFF AND FOUND IN PT. DELAYED SURGERY FOR 5 MINUTES, DOCTOR WAS ABLE TO COMPLETE THE CASE WITH ANOTHER STRYKER PROBE.

    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 08071AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK