BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIVAC 50 XL, 3MM WITH INTEGRATED CABLE

    MDR report key: 2011753 · Received March 3, 2011

    Report

    Report Number
    2951580-2011-00033
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    January 20, 2011
    Report Date
    March 3, 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

    PT'S INFO WAS REQUESTED, BUT COMPANY REP REPORTED DOCTOR CANNOT REMEMBER ANY PT INFO. DATE OF EVENT WAS REPORTED AS NEAR (B)(6) 2011. EXACT DATE WAS NOT PROVIDED. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE PROVIDED WITH THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING A HIP PROCEDURE USING A MULTIVAC 50 XL ARTHROWAND, ALLEGEDLY THE SCREEN FROM THE ARTHROWAND DETACHED. DOCTOR REPORTED HE COULDN'T FIND THE SCREEN AND IT MIGHT HAVE FALLEN IN THE PT'S HIP. AN X-RAY WAS NOT PERFORMED AND A SECOND PROCEDURE IS NOT NECESSARY AT THIS TIME. THERE WAS NO REPORTED PT ADVERSE EFFECT OR PT INJURY. NO OTHER INFO WAS PROVIDED FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVAC 50 XL, 3MM WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP EF25100-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other