BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 473571 · Received July 21, 2003

    Report

    Report Number
    MW1029035
    Event Type
    Malfunction
    Date Received
    July 21, 2003
    Date of Event
    July 14, 2003
    Report Date
    July 21, 2003
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED FOR AN OPEN GASTRIC BYPASS. DURING THE CASE TWO STAPLERS WERE OPENED TO CREATE ANASTOMIES OF THE BOWEL. DURING THE FIRING OF ONE OF THE STAPLERS, THE COCKING PIN PLUNGED THROUGH THE STAPLE ANVIL FORMING A SHARP POINT. THE STAPLER WAS THEN REMOVED FROM THE FIELD, AND THE SECOND STAPLER WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. PROXIMATE RELOADABLE LINEAR STAPLER GAG ETHICON ENDO-SURGERY, INC. TX60G R4U18H
    2 ETHICON ENDO-SURGERY, INC. PROXIMATE RELOADABLE LINEAR STAPLER GAG ETHICON ENDO-SURGERY, INC. TX60G R4RP7A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other