BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGIN

    MDR report key: 67187 · Received December 31, 1996

    Report

    Report Number
    67187
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    August 30, 1996
    Report Date
    September 11, 1996
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE FOR RIGHT INGUINAL HERNIA THE END OF THE TROCAR SLEEVE SPLINTERED AND BROKE OFF IN THE PT. THE INCISION WAS MADE LARGER AND THE BROKEN PIECE WAS RETRIEVED AND REMOVED. PT HAD NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN TROCAR SLEEVE GCJ ORIGIN MEDSYSTEMS, INC. TROCAR SLEEVE 1306961

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention LOT #2006961, MFG. PART #06888, SIZE 5MM| ORIGIN THREADED GRIPPER OMS-G5T