BEUDAMED
    FDA Adverse Event Other Summary report: N

    REFLEX ULTRA PTR WITH INTEGRATED CABLE

    MDR report key: 2094054 · Received April 29, 2011

    Report

    Report Number
    2951580-2011-00056
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K070374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT WAS REQUESTED AND PROVIDED AS 3 TO 5 WEEKS AFTER THE ORIGINAL PROCEDURE. AN APPROXIMATE DATE OF EVENT WAS PROVIDED. SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED AND THE LOT NUMBER IS NOT KNOWN, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. NO CONCLUSION CAN BE MADE. A SECOND DEVICE, COBLATOR II SYS, USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2951580-2011-00055.

    Description of Event or Problem · 1

    THE PT UNDERWENT A TURBINATE REDUCTION PROCEDURE USING A COBLATOR II SYS AND AN REFLEX ULTRA PTR PLASMAWAND WITH INTEGRATED CABLE. THE PT REQUIRED TREATMENT AT AN EMERGENCY ROOM FOR POST OPERATIVE BLEEDING ON (B)(6) 2011. NASAL PACKING WAS ADMINISTERED TO STOP THE BLEEDING. NASAL PACKING WAS REMOVED AFTER 4 TO 5 DAYS AND PT HAD NO OTHER BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX ULTRA PTR WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other