BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 2133202 · Received May 9, 2011

    Report

    Report Number
    2648666-2011-00129
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON COMPLETION OF A CASE, THE PLASTIC OF THE PRODUCT HAD MELTED. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES OR DELAYS TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90-S SERFAS ENERGY SUCTION PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK