BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON RETICULATING LINEAR CUTTER

    MDR report key: 199269 · Received November 17, 1998

    Report

    Report Number
    199269
    Event Type
    Injury
    Date Received
    November 17, 1998
    Date of Event
    October 20, 1998
    Report Date
    November 17, 1998
    Manufacturer
    ETHICON ENDO-SURGERY CUSTOMER RESPONSE CENTER
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING ENDOSCOPIC RETICULATING LINEAR CUTTER, THE RELOAD UNIT FELL OUT OF THE STAPLER INTO THE CHEST CAVITY. ADDITIONAL 8 INCH INCISION WAS MADE AND A VIDEO ASSISTED THORACOTOMY PERFORMED TO RETRIEVE THE RELOAD UNIT. PLEASE REFER TO REPORT #98-210015-00008 SUBMITTED UNDER THE VOLUNTARY REPORTING REQUIREMENTS. ACCESS NO: MW 1014875.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON RETICULATING LINEAR CUTTER RETICULATING STAPLER GAG ETHICON ENDO-SURGERY CUSTOMER RESPONSE CENTER 35 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention