BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 1052211 · Received May 21, 2008

    Report

    Report Number
    2648666-2008-00061
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CERAMIC TIP BROKE OFF IN SHOULDER. TIP WAS RETRIEVED FROM PATIENT'S SHOULDER. DELAYED SURGERY FOR 20 MINUTES. DOCTOR THEN WAS ABLE TO CONTINUE CASE.

    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 07283AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK