BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 2190333 · Received July 27, 2011

    Report

    Report Number
    2648666-2011-00176
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    November 3, 2010
    Report Date
    July 14, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COMPLAINED OF PAIN IN A PARTICULAR AREA FOLLOWING A PROCEDURE. FURTHER, A SECOND PROCEDURE WAS DONE. IT WAS SUGGESTED THAT THE PAIN WAS CAUSED BY A FOREIGN BODY THAT WAS FOUND IN THE PT, THE TIP OF THE PROBE. FURTHER, THE FACILITY CLAIMS THAT THEY HAD NOT NOTICED THAT THEY WERE MISSING PART OF THE PROBE UNTIL IT WAS FOUND DURING THE SECOND PROCEDURE. FURTHER, THE PROBE TIP WAS RETRIEVED AND AVAILABLE FOR EVAL. FURTHER, THERE WAS NO ADVERSE ENVIRONMENTAL CONDITIONS AT THE TIME THE EVENT OCCURRED. FURTHER, THERE WAS NO REPAIRS DONE ON THE DEVICE ON EITHER SURGERY.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK