BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ULTRA PTR WITH INTEGRATED CABLE

    MDR report key: 3063347 · Received April 11, 2013

    Report

    Report Number
    3006524618-2013-00148
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TURBINECTOMY PROCEDURE USING THE REFLEX ULTRA PTR WAND, THE WAND TIP ALLEGEDLY SPARKED AND SMOKED. THE SURGEON REMOVED THE WAND FROM THE SURGICAL SITE AND NOTICED THAT THE TIP OF THE WAND APPEARED TO BE MISSING. THERE WAS A 60 MINUTE SURGICAL DELAY WHILE THE SURGEON LOOKED FOR THE TIP, BUT NOTHING WAS FOUND. AN XRAY WAS TAKEN AS A PRECAUTION AND THERE WAS NO VISIBLE DEBRIS IN THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH A BACK UP WAND AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156997 REFLEX ULTRA PTR WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION AS03120-A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other