BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERC DC CONVENIENCE PACK

    MDR report key: 1010129 · Received March 12, 2008

    Report

    Report Number
    2951580-2008-00015
    Event Type
    Other
    Date Received
    March 12, 2008
    Date of Event
    January 15, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K010811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR INVESTIGATION. AWAITING RETURN OF THE DEVICE TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING A PERC DC WAND WAS REPORTED TO ARTHROCARE. DURING A CERVICAL NUCLEOPLASTY PROCEDURE, THE TIP OF THE PERC DC WAND DETACHED AND REMAINED IN THE PT'S CERVICAL DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC DC CONVENIENCE PACK ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA Q017670-A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other