BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 1940249 · Received December 9, 2010

    Report

    Report Number
    2648666-2010-00481
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE UNIT BROKE OFF AND FELL INTO THE PT. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS RETRIEVED AND ANOTHER UNIT WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PT.

    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 10270AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK