BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RH SKIN STAPLER

    MDR report key: 2800991 · Received September 27, 2012

    Report

    Report Number
    2800991
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    May 7, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN'S ASSISTANT INSERTED THE DEVICE. THE TWO ENDS WERE CONNECTED AND FIRED. THERE WAS A MISFIRING OF THE DEVICE ON REMOVING IT. THE RIGHT SIDE OF THE ANASTOMOSIS OPENED UP. THE SURGEON THEN REPAIRED THE SITE WITH SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RH SKIN STAPLER STAPLER GAG ETHICON ENDO-SURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR