BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPS-LOCK CANNULA

    MDR report key: 2822930 · Received October 23, 2012

    Report

    Report Number
    3006524618-2012-00829
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MFR NARRATIVE: THE PT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER MEMBRANE OF THE CANNULA FRAGMENTED AND WAS FORCED INTO JOINT SPACE BY THE INSTRUMENT. MEMBRANE FRAGMENT WAS REMOVED WITHOUT INCIDENT. PROCEDURE WAS COMPLETED WITH ANOTHER CAPS-LOCK CANNULA WITHOUT FURTHER INCIDENT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPS-LOCK CANNULA CANNULA GEI ARTHROCARE CORPORATION M201717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention