BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSING TIP TROCAR

    MDR report key: 83468 · Received April 10, 1997

    Report

    Report Number
    2939738-1997-00017
    Event Type
    Injury
    Date Received
    April 10, 1997
    Date of Event
    February 13, 1997
    Report Date
    March 14, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE PT'S BOWEL WAS ALLEGEDLY PERFORATED BY THE TROCAR SLEEVE END. THE TEAR WAS SUTURED LAPAROSCOPICALLY. THE DEVICE HISTORY RECORD REVIEW INDICATED NO LOT SPECIFIC PROBLEM. THE RETURNED UNIT SHOWED A CLEAR SIGN OF MISUSE. THE INSTRUCTIONS FOR USE WARN TO EXERCISE CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSING TIP TROCAR RETRACTION TROCAR GCJ ORIGIN MEDSYSTEMS, INC. OMS-T5S 1412951

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R