BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSING TIP OBTURATOR

    MDR report key: 97536 · Received June 7, 1997

    Report

    Report Number
    97536
    Event Type
    Other
    Date Received
    June 7, 1997
    Date of Event
    April 5, 1997
    Report Date
    May 9, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORIGIN GUARD DID NOT RELEASE AFTER ENTERING THE LAPAROSCOPIC ABDOMINAL SITE CAUSING A SUPERFICIAL SMALL LACERATION TO THE LIVER. THE CUSTOMER REPORTED THAT THE TROCAR ALLEGEDLY FAILED TO RETRACT. THE DEVICE HISTORY RECORD REVIEW INDICATED NO LOT SPECIFIC PROBLEM IN THE DHR. IN ADDITION, FINISHED GOODS LOCATION WAS CHECKED FOR ANY INVENTORY CONTAINING THE LOT NUMBER. UNFORTUNATELY, NO UNITS WITH THAT LOT NUMBER WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSING TIP OBTURATOR RETRACTION TROCAR GCJ ORIGIN MEDSYSTEMS, INC. OMS-T10SO 0212921

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other