BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR ESS II RP

    MDR report key: 1095463 · Received July 24, 2008

    Report

    Report Number
    1095463
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 24, 2008
    Manufacturer
    PHOTOMEDEX, INC.
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT THE CLEAR ESS II RP SUCTION AND IRRIGATION TUBING WAS STUCK SO IT WAS CONSTANTLY ON. THE PHYSICIAN WAS UNABLE TO GET THE DEVICE TO IRRIGATE PROPERLY. NEW CLEAR ESS TUBING WAS OBTAINED WHICH FUNCTIONED APPROPRIATELY. WE HAVE HAD FOUR SEPARATE INCIDENTS OF THIS PROBLEM, AND IT APPEARS THAT THE SAME LOT NUMBER HAS BEEN INVOLVED IN THREE OF THESE CASES. THEREFORE, THE LOT HAS BEEN REMOVED FROM THE SHELVES AND THE DEVICES WILL BE RETURNED TO THE MANUFACTURER, AS THEY HAVE ASKED US TO RETURN PRODUCT FOR EVALUATION. WE ARE IN THE PROCESS OF GETTING A RETURN AUTHORIZATION NUMBER SO THAT WE CAN RETURN THESE DEVICES TO THEM. THERE HAS BEEN NO PATIENT HARM AS A RESULT OF THESE FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR ESS II RP TUBING, SUCTION IRRIGATION JCX PHOTOMEDEX, INC. 0041-6153 805606
    2 CLEAR ESS II RP TUBING, SUCTION IRRIGATION JCX PHOTOMEDEX, INC. 0041-6153 805606
    3 CLEAR ESS II RP TUBING, SUCTION IRRIGATION JCX PHOTOMEDEX, INC. 0041-6153 805606
    4 CLEAR ESS II RP TUBING, SUCTION IRRIGATION JCX PHOTOMEDEX, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR