BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW, VV3 CANNULA (BDC)

    MDR report key: 183587 · Received August 20, 1998

    Report

    Report Number
    2939738-1998-00011
    Event Type
    Injury
    Date Received
    August 20, 1998
    Date of Event
    July 9, 1998
    Report Date
    July 20, 1998
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SAPHENOUS VEIN HARVESTING PROCEDURE A PT'S LEG WOUNDS BECAME SEPTIC. THERE WAS NO REPORTED DEFECT OR MALFUNCTION ASSOCIATED WITH THE DEVICE. THE SURGEON WAS UNSURE IF ANY OR ORIGIN'S PRODUCTS ACTUALLY CAUSED THE INFECTION. THE PT'S HOSP STAY WAS PROLONGED FOR MONITORING PURPOSES. THE PT HAS SUBSEQUENTLY BEEN RELEASED. THE HOSP IS CONDUCTING A CLOSED INVESTIGATION OF THE EVENT AND IS TESTING ALL EQUIPMENT, TOOLS, STERILIZATION METHODS, ETC. FOR POSSIBLE SOURCES OF CONTAMINATION IN ADDITION TO ORIGIN PRODUCTS. ORIGINAL UNITS WERE DISPOSED OF BY THE HOSP STAFF. EIGHT UNUSED SAMPLES WERE RETURNED FOR EVALUATION, IN ADDITION THE SALES REP HAS RETURNED 16 UNUSED KITS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW, VV3 CANNULA (BDC) VAOSVIEW GCJ ORIGIN MEDSYSTEMS, INC. OMS-BDC 1506981

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R OMS-BSZ, OMS-CD, OMS-BT12SL.| OTHER DEVICES USED DURING SURGERY: OMS-US,