BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIDEWINDER BLADE ICQ

    MDR report key: 2654556 · Received July 11, 2012

    Report

    Report Number
    3006524618-2012-00627
    Event Type
    Injury
    Date Received
    July 11, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS MANUFACTURED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE PHYSICIAN BEGAN TO REMOVE THE SIDEWINDER BLADE ICW ARTHROWAND FROM THE TROCAR, THE TIP AND CAP DETACHED. THE PIECES WERE VISUALIZED IN THE JOINT SPACE. THE PHYSICIAN IS NOT CONFIDENT THAT ALL THE DEVICE FRAGMENTS WERE REMOVED FROM THE SURGICAL SITE. IT IS BELIEVED THAT THE DEVICE FRAGMENTS MAY HAVE BEEN REMOVED VIA SUCTION, SINCE SEVERAL X-RAYS WERE TAKEN AND NO DEVICE FRAGMENTS COULD BE SEEN. THE SURGICAL PROCEDURE HAD ALREADY BEEN COMPLETED, HOWEVER, THE TIP DETACHMENT CAUSE AN APPROXIMATE 15 - 30 MINUTE DELAY. NO PT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDEWINDER BLADE ICQ ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORPORATION 6905320-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R