BEUDAMED
    FDA Adverse Event Other Summary report: N

    COVAC 70 WAND, 3.0 MM WITH INTEGRATED CABLE

    MDR report key: 2011917 · Received February 25, 2011

    Report

    Report Number
    2951580-2011-00014
    Event Type
    Other
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ARTHROCARE CORP
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE PROVIDED ONCE THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW ARE COMPLETE.

    Description of Event or Problem · 1

    DURING A KNEE SCOPE PROCEDURE USING A COVAC 70 WAND 3.0 MM WITH INTEGRATED CABLE, THE TIP OF THE ARTHROWAND FELL IN THE PT. IT WAS REPORTED THAT THE TIP WAS RETRIEVED WITH A GRASPER IN THE SAME PROCEDURE. A C-ARM WAS USED TO CONFIRM THAT ALL PIECES WERE RETRIEVED. THERE WAS NO REPORTED PT INJURY OR ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVAC 70 WAND, 3.0 MM WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP S613700-A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other