BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSING TIP TROCAR

    MDR report key: 144741 · Received January 15, 1998

    Report

    Report Number
    2939738-1997-00040
    Event Type
    Injury
    Date Received
    January 15, 1998
    Date of Event
    September 15, 1997
    Report Date
    December 1, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PELVISCOPY PROCEDURE, THE PT'S BOWEL WAS INJURED WHILE THE DOCTOR WAS USING A RETRACTION TROCAR. A GENERAL SURGEON WAS CALLED IN TO REPAIR THE BOWEL. THE PT IS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSING TIP TROCAR RETRACTION TROCAR GCJ ORIGIN MEDSYSTEMS, INC. OMS-T1112S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R