BEUDAMED
    FDA Adverse Event Summary report: N

    3.5MM 90 SERFAS ENERGY PROBE

    MDR report key: 1032049 · Received April 14, 2008

    Report

    Report Number
    2648666-2008-00045
    Date Received
    April 14, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 19, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICED NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PART OF THE PLASTIC TIP BROKE OFF THE PROBE INSIDE THE PT. THE SERFAS WAS RUNNING 5 WHEN IT BROKE OFF. THIS OCCURRED IN THE FIRST MINUTE OF THE CASE. ALL PIECES WERE RECOVERED AND "SUCKED OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90 SERFAS ENERGY PROBE SERFAS PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 08045AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK