BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPAZ MICRODEBRIDER W / INTEGRATED FINGER SWITCH

    MDR report key: 2271737 · Received September 28, 2011

    Report

    Report Number
    2951580-2011-00145
    Event Type
    Injury
    Date Received
    September 28, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K080282
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST TOPAZ WAND USED IN THIS PROCEDURE HAS BEEN FILED UNDER MDR 2951580-2011-00144. THE CONTROLLER UNIT USED IN THIS PROCEDURE HAS BEEN FILED UNDER MDR 2951580-2011-00146.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE THE PHYSICIAN WAS USING A TOPAZ MICRODEBRIDER WITH THE QUANTUM II CONTROLLER SYSTEM. DURING THE PROCEDURE THE FIRST TOPAZ WAND MALFUNCTIONED AND HAD AN OBSTRUCTED SALINE FLOW. THE PHYSICIAN RETRIEVED A SECOND TOPAZ WAND WHICH RESULTED IN A 2-3 MINUTE DELAY. IT WAS REPORTED THAT THE DISTAL END OF THE SECOND TOPAZ WAND, LOT #AT12910-A FELL OFF INTO THE PT. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE ANY OF THE DEBRIS FRAGMENTS. THE PT WAS TREATED WITH ANTIBIOTICS PRE AND POST-OPERATIVELY. IT WAS REPORTED THAT THE PT IS RECOVERING NORMALLY WITH NO ADVERSE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOPAZ MICRODEBRIDER W / INTEGRATED FINGER SWITCH ELECTROSURGICAL CUTTING & COAGULATION GEI ARTHROCARE CORP. AT1290-A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention