BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ARTICULATING LINEAR STAPLER

    MDR report key: 692016 · Received March 22, 2006

    Report

    Report Number
    1527736-2006-01284
    Event Type
    Malfunction
    Date Received
    March 22, 2006
    Date of Event
    February 22, 2006
    Report Date
    March 2, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE,THE DEVICE WAS FIRED AND THE STAPLES DID NOT FORM AND FELL OUT.UNK HOE THE CASE COMPLETED.NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ARTICULATING LINEAR STAPLER GDW GAG ETHICON ENDO-SURGERY, INC. NA A4C29M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN