BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 1024222 · Received March 27, 2008

    Report

    Report Number
    2648666-2008-00035
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 27, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT THE WHITE TIP THAT CONNECTS THE SUCTION BROKE OFF OF THE SERFAS PROBE DURING PREPARATION.

    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 07340AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK