BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 2132430 · Received June 16, 2011

    Report

    Report Number
    2132430
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PULLING (FIRING) THE HANDLE (STAPLER), THE STAPLES INSERTED INTO THE TISSUE BUT, NEVER CLOSED (STAPLES DID NOT FORM) INCREASING THE SURGICAL TIME BY AN EXTRA HOUR TO AN HOUR AND A HALF. MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, PROXIMATE (PER SITE REPORTER): REPRESENTATIVE WILL SEND A RELEASE LETTER TO US AND THE PRODUCT WILL BE RETURNED TOMORROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. TX60B H43D9M

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR