BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX

    MDR report key: 1548230 · Received November 7, 2009

    Report

    Report Number
    1548230
    Event Type
    Malfunction
    Date Received
    November 7, 2009
    Date of Event
    September 21, 2009
    Report Date
    November 7, 2009
    Manufacturer
    INAVEIN, LLC
    Product Code
    DWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR A LEFT SAPHENOUS VEIN RIGHT FEMORAL ARTERY WITH TRIVEX, PRONE AND SUPINE. THE TRIVEX MACHINE WORKED PERFECTLY FOR THE FIRST HALF OF THE CASE WHILE THE PT WAS IN THE PRONE POSITION. THE PATIENT WAS TURNED, AND PROCEEDED ON WITH THE SUPINE PORTION OF THE CASE. THE TRIVEX WAS WORKING WELL FOR ABOUT 20 MINS OR SO AND THEN THE RESECTOR PORTION STOPPED WORKING. AT THIS TIME, THE RESECTOR WAS RE-EXAMINED. THE RESECTOR HANDPIECE WAS TAKEN APART AND THE NON-DISPOSABLE PORTION HAS A WHEEL THAT SPINS TO TURN THE BLADE ON THE DISPOSABLE RESECTOR. THE WHEEL WAS NOT SPINNING. THE TRIVEX MACHINE WAS TURNED OFF AND ON SEVERAL TIMES. THE HANDPIECES WERE PLUGGED AND UNPLUGGED. AT THIS POINT THE LIGHTS ON THE MACHINE (THAT ARE SUPPOSED TO BE GREEN) HAVE TURNED ORANGE AND WILL NOT TURN BACK TO GREEN. BIOMED AND CHARGE NURSE WERE NOTIFIED. BIOMED TECH CAME TO THE OR TO INSPECT THE MACHINE. SHE DID ALL THE THINGS THAT WE DID AS WELL. WE ALSO OPENED A NEW DISPOSABLE AND NON-DISPOSABLE HANDPIECE RESECTOR. THESE CHANGES DID NOT HELP. TECH LEFT THE ROOM TO READ THE MANUAL ON THE TRIVEX. SHE CAME BACK AND STATED THAT FROM OUR DESCRIPTION, THE RESPONSES FROM THE MACHINE AND THE MANUAL, THAT IT APPREARED TO BE A MOTHERBOARD FAILURE. SURGEON FINISHED THE REST OF THE CASE WITH STAB PHLEBECTOMIES. NO IMMEDIATE HARM CAME TO THE PT FROM THE MACHINE NOT WORKING.

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR A LEFT SAPHENOUS VEIN RIGHT FEMORAL ARTERY WITH TRIVEX, PRONE AND SUPINE. THE TRIVEX MACHINE WORKED PERFECTLY FOR THE FIRST HALF OF THE CASE WHILE THE PT WAS IN THE PRONE POSITION. THE PATIENT WAS TURNED, AND PROCEEDED ON WITH THE SUPINE PORTION OF THE CASE. THE TRIVEX WAS WORKING WELL FOR ABOUT 20 MINS OR SO AND THEN THE RESECTOR PORTION STOPPED WORKING. AT THIS TIME, THE RESECTOR WAS RE-EXAMINED. THE RESECTOR HANDPIECE WAS TAKEN APART AND THE NON-DISPOSABLE PORTION HAS A WHEEL THAT SPINS TO TURN THE BLADE ON THE DISPOSABLE RESECTOR. THE WHEEL WAS NOT SPINNING. THE TRIVEX MACHINE WAS TURNED OFF AND ON SEVERAL TIMES. THE HANDPIECES WERE PLUGGED AND UNPLUGGED. AT THIS POINT THE LIGHTS ON THE MACHINE (THAT ARE SUPPOSED TO BE GREEN) HAVE TURNED ORANGE AND WILL NOT TURN BACK TO GREEN. BIOMED AND CHARGE NURSE WERE NOTIFIED. BIOMED TECH CAME TO THE OR TO INSPECT THE MACHINE. SHE DID ALL THE THINGS THAT WE DID AS WELL. WE ALSO OPENED A NEW DISPOSABLE AND NON-DISPOSABLE HANDPIECE RESECTOR. THESE CHANGES DID NOT HELP. TECH LEFT THE ROOM TO READ THE MANUAL ON THE TRIVEX. SHE CAME BACK AND STATED THAT FROM OUR DESCRIPTION, THE RESPONSES FROM THE MACHINE AND THE MANUAL, THAT IT APPREARED TO BE A MOTHERBOARD FAILURE. SURGEON FINISHED THE REST OF THE CASE WITH STAB PHLEBECTOMIES. NO IMMEDIATE HARM CAME TO THE PT FROM THE MACHINE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIVEX LASER, ENDOVENOUS DEVICE DWQ INAVEIN, LLC INAVEIN TRIVEX SYSTEM *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR