BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 IFS

    MDR report key: 5051814 · Received September 2, 2015

    Report

    Report Number
    3006524618-2015-00506
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 13, 2015
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    BWA
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE DEVICE HAS NOT BEEN RETURNED. DUE TO THIS FACT WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW CONFIRMED THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING AN AMBIENT SUPER TURBOVAC WAND, A METALLIC FRAGMENT FLAKED OFF OF THE WAND AND FELL INTO THE JOINT. IT COULD NOT BE CONFIRMED IF THE FRAGMENT WAS RETRIEVED OR LEFT INSIDE THE PATIENT. NO FURTHER DETAILS HAVE BEEN PROVIDED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581931 AMBIENT SUPER TURBOVAC 90 IFS SHOULDER PROBES BWA ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1