BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOPAZ MICRODEBRIDER WITH INTEGRATED FINGER SWI

    MDR report key: 2170185 · Received June 29, 2011

    Report

    Report Number
    2951580-2011-00085
    Event Type
    Other
    Date Received
    June 29, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K080282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AGE WAS REQUESTED, BUT TO DATE, HAS NOT BEEN PROVIDED. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE LOT HISTORY RECORD WAS REVIEWED, AND NO ABNORMALITIES WERE FOUND IN THE LOT HISTORY RECORD REVIEW. THE LOT MET ALL DEVICE SPECIFICATIONS. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    DURING A PLANTAR FASCIA PROCEDURE, USING A TOPAZ MICRODEBRIDER WITH INTEGRATED FINGER SWITCH ARTHROWAND, THE TIP OF THE WAND ALLEGEDLY BROKE OFF IN THE SURGICAL SITE. IT WAS REPORTED THAT THE TIP WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS NOT COMPLETED AS A BACKUP WAND WAS NOT AVAILABLE, AND A SECOND PROCEDURE IS NOT SCHEDULED AT THIS TIME. THERE IS NO REPORTED PT INJURY OR ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOPAZ MICRODEBRIDER WITH INTEGRATED FINGER SWI ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION AT03110-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other