BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 1963285 · Received January 6, 2011

    Report

    Report Number
    2648666-2011-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 19, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    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 THE UNIT ACTIVATED ITSELF. IT WAS FURTHER REPORTED THAT THE SALINE POUCH WAS OUTSIDE OF THE PT AND NOT IN USE WHEN THE EVENT OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK