BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM II SYSTEM

    MDR report key: 2271753 · Received September 28, 2011

    Report

    Report Number
    2951580-2011-00146
    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
    K082666
    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 SECOND TOPAZ WAND USED IN THIS PROCEDURE HAS BEEN FILED UNDER MDR 2951580-2011-00145.

    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 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 QUANTUM II SYSTEM ELECTROSURGICAL CUTTING & COAGULATION GEI ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention