BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSING TIP TROCAR OBTURATOR, 5MM

    MDR report key: 198244 · Received November 14, 1998

    Report

    Report Number
    2939738-1998-00019
    Event Type
    Death
    Date Received
    November 14, 1998
    Date of Event
    September 14, 1998
    Report Date
    October 15, 1998
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, A 74 Y/O MALE PT SUFFERED A PERFORATION AND SUBSEQUENTLY DIED. DURING THE PROCEDURE, THE PT'S SMALL BOWEL REPORTEDLY SUSTAINED A PERFORATION WHILE THE TROCAR WAS BEING USED, BUT WAS NOT DETECTED AT THE TIME OF THE INITIAL SURGERY. THE PT THEN RETURNED TO O/R, A BOWEL TEAR WAS DETECTED IN THE PT'S BOWEL, AND SUCCESSFULLY REPAIRED. THE PT WAS LISTED IN GOOD CONDITION IMMEDIATELY AFTER THE SECOND PROCEDURE. ABOUT 4-5 DAYS AFTER THE SURGERY, THE PT'S STATUS DIMINISHED AND WAS TRANSFERRED TO AN INTENSIVE CARE UNIT. THE PT EXPIRED SHORTLY THEREAFTER. THE SURGEON THAT PERFORMED THE INITIAL SURGERY REPORTED THERE HAD BEEN NO INDICATION OF A PROBLEM WITH THE TROCAR DURING ITS USE AND COMMENTED THAT THE UNIT HAD FUNCTIONED CORRECTLY. THE DEVICE USED WAS DISPOSED SINCE THE INITIAL CASE WAS THOUGHT TO HAVE BEEN COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSING TIP TROCAR OBTURATOR, 5MM RETRACTION TROCAR (SENSING TIP) GCJ ORIGIN MEDSYSTEMS, INC. OMS-T5SO NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| L| R OMS-TC10, OMS-TC5 (2EA.), OMS-T10BT.