BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 1111943 · Received August 11, 2008

    Report

    Report Number
    2648666-2008-00083
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    OUR DISTRIBUTOR HAS ALLEGED THAT DURING THE SURGERY, THE ITEM "BLEW UP". PART OF THE ITEM WAS RETRIEVED COMPLETELY FROM THE BODY OF THE PT. THE SURGERY WAS ABLE TO FINISH WITH ANOTHER ITEM THAT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 07141AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK