BEUDAMED
    FDA Adverse Event Summary report: N

    POWERSUITE 20W

    MDR report key: 3841143 · Received May 30, 2014

    Report

    Report Number
    3004135191-2014-00035
    Date Received
    May 30, 2014
    Date of Event
    March 12, 2014
    Report Date
    May 30, 2014
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K011703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE USER FACILITY TO OBTAIN FURTHER INFORMATION ABOUT THE INCIDENT REPORT. NO SUBJECT DEVICE LASER MALFUNCTION WAS REPORTED; THEREFORE NO EXAMINATION OF THE SUBJECT DEVICE LASER OCCURRED. SUBJECT DEVICE LASER MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENT REPORTED. TO THE BEST KNOWLEDGE OF LUMENIS, THE SUBJECT DEVICE LASER REMAINS IN USE AT THE USER FACILITY. FOLLOWING A REVIEW OF THE EVENT REPORT BY A LUMENIS TECHNICAL EXPERT THE EXPERT STATED, "USING A NON LUMENIS FIBER MAY WORK BUT WE DO NOT RECOMMEND IT AND THESE FIBERS WERE NOT QUALIFIED ON OUR SYSTEM." LUMENIS HAS NOT QUALIFIED 272 SCOPESAFE FIBERS FOR USE ON LUMENIS POWERSUITE LASERS. USE OF A NON-QUALIFIED ACCESSORY IS THE DETERMINE CAUSE OF THE EVENT REPORTED. NO SUBJECT DEVICE MALFUNCTION REPORTED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED ON (B)(4) THAT, "THE PHYSICIAN WAS GETTING READY TO USE THE HOLMIUM LASER AND WHEN CONNECTED THE 272 SCOPESAFE WIRE TO THE LASER MACHINE, IT WOULD NOT RECOGNIZE THAT THE WIRE WAS CONNECTED. TRIED A SECOND 272 SCOPESAFE AND IT DID NOT WORK EITHER. FINALLY OPENED A 200 SLIMLINE LASER FIBER AND IT WAS RECOGNIZED AND WORKED SO THE PHYSICIAN WAS ABLE TO CONTINUE WITH THE PROCEDURE." NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319270 POWERSUITE 20W HOLMIUM LASER SURGICAL DELIVERY DEVICE GEX LUMENIS, LTD. POWERSUITE 20W

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other SCOPESAFE 272 LASER WIRE