BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURBOVAC 90 3.5MM 90 DEG. SUCTION

    MDR report key: 2011849 · Received February 25, 2011

    Report

    Report Number
    2951580-2011-00005
    Event Type
    Other
    Date Received
    February 25, 2011
    Date of Event
    January 1, 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
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS REQUESTED. TO DATE, INFO HAS NOT BEEN RECEIVED. THE DEVICE WAS REPORTED AS RETURNING. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING A TURBOVAC 90 3.5MM 90 DEG. SUCTION ARTHROWAND WAS REPORTED TO ARTHROCARE. DURING A SHOULDER ARTHROSCOPIC SUBACROMIAL DECOMPRESSION PROCEDURE, A SMALL TRANSPARENT PLASTIC PIECE BROKE OFF THE DISTAL TIP OF THE ARTHROWAND AND VANISHED NOT TO BE FOUND. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOVAC 90 3.5MM 90 DEG. SUCTION ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other