BEUDAMED
    FDA Adverse Event Other Summary report: N

    INAVEIN TRIVEX SYSTEM - RESECTOR HANDPIECE

    MDR report key: 2605018 · Received September 17, 2008

    Report

    Report Number
    3006891502-2008-00003
    Event Type
    Other
    Date Received
    September 17, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 2008
    Manufacturer
    INAVEIN, LLC
    Product Code
    DWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION DATA: PRELIMINARY EVALUATION - THE TRIVEX CONTROL UNIT (SN (B)(4)) WAS RETURNED AND FUNCTIONALLY TESTED TO DETERMINE IF THE REPORTED PROBLEM COULD BE CONFIRMED. THE UNIT WAS POWERED ON AND TESTED CONTINUOUSLY FOR 8 CONSECUTIVE HOURS. DURING THIS TIME THE RESECTOR DRIVE UNITS (SN (B)(4) AND (B)(4)) WERE ATTACHED TO THE CONTROL UNIT FOR 4 HOURS EACH. DURING THIS EVALUATION THE RESECTOR HAND PIECES REMAINED IDLE AND DID NOT ROTATE. THE RESECTORS WERE THEN FUNCTIONALLY TESTED AND IT WAS DETERMINED THAT THE UNITS PERFORMED TO SPECIFICATION. NO ISSUES WERE NOTED WITH THE CONTROL UNIT OR THE RESECTOR HANDPIECES. DETAILED EVALUATION - THE TRIVEX CONTROL UNITS AND HANDHELD RESECTOR DRIVE UNITS WERE THEN FORWARDED TO THE MANUFACTURING FLOOR FOR A DETAILED ANALYSIS. THE CONTROL UNIT WAS DISASSEMBLED AND REVIEWED. IT WAS NOTED THAT ONE COOLING FAN CABLE WAS DISCONNECTED. ALL OTHER COMPONENTS WERE IN WORKING ORDER. THE FAN CABLE WAS RECONNECTED AND FOUND TO FUNCTION PROPERLY. THE HANDHELD RESECTOR UNITS WERE ALSO EXAMINED AND WERE FOUND TO BE IN NORMAL WORKING ORDER.

    Description of Event or Problem · 1

    A (B)(6) FEMALE UNDERWENT A TRANSILLUMINATED POWERED PHLEBECTOMY PROCEDURE. AFTER THE PROCEDURE, SURGICAL STAFF NOTED TWO SMALL LACERATIONS ABOVE THE PT'S LEFT KNEE. OPERATING ROOM STAFF REPORTED THAT THE LACERATIONS APPEARED TO HAVE BEEN CAUSED BY THE HANDHELD RESECTOR DURING SURGERY WHEN IT WAS PLACED ON THE SURGICAL DRAPE COVERING THE PT. OPERATING ROOM STAFF FURTHER REPORTED THAT THE RESECTOR HAD STARTED AND STOPPED ROTATING WITHOUT CONTROL BY THE OPERATOR. THE SURGICAL SYSTEM CONTROL UNIT (MODEL #7210386 SN (B)(4)) AND TWO RESECTOR DRIVE UNITS (MODEL #7210387 SN (B)(4) AND SN (B)(4)) WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE USER FACILITY DID NOT INDICATE WHICH RESECTOR UNIT WAS USED DURING THE PROCEDURE. THE PT'S LACERATIONS DID NOT REQUIRE SUTURES OR SPECIAL DRESSINGS. THE PT WAS TREATED AND THEN RELEASED FROM THE HOSPITAL. ON (B)(6), A FOLLOW UP CALL TO THE PT BY HOSPITAL STAFF INDICATED THAT THE PT WAS FINE. NOTE: REPORT FOR DEVICE 3 OF 3 NOTED ABOVE - MODEL #7210387, SERIAL #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INAVEIN TRIVEX SYSTEM - RESECTOR HANDPIECE DWQ - VARICOSE VEIN ABLATION SYSTEM DWQ INAVEIN, LLC 7210387

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other NO INFO PROVIDED BY USER FACILITY.