BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SOLUTION PROBE

    MDR report key: 2182066 · Received June 23, 2011

    Report

    Report Number
    2648666-2011-00162
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE THE SCREEN ON THE TIP OF THE PROBE UNIT FELL OFF INTO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90-S SERFAS ENERGY SOLUTION PROBE SUCTION PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 11130AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK