BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDOSURGERY, INC.

    MDR report key: 219483 · Received March 31, 1999

    Report

    Report Number
    219483
    Event Type
    Injury
    Date Received
    March 31, 1999
    Date of Event
    March 3, 1999
    Report Date
    March 10, 1999
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING DEVICE THE TROCAR BUTTON DID NOT "POP UP" SO THE ACTIVE SHIELD NEVER LOCKED INTO PLACE. PT REQUIRED SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOSURGERY, INC. TROCAR OBTURATOR AND HOUSING ASSEMBLY GCJ ETHICON ENDO-SURGERY * M4D481-MAY NOT BE FROM SAME LO

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention