BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 100-3.8 SINGLE USE RELOADABLE

    MDR report key: 4009307 · Received July 30, 2014

    Report

    Report Number
    2647580-2014-00595
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 8, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICAN
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PANCREAS. ACCORDING TO THE REPORTER: AFTER THE FIRST FIRING WAS DONE A DOCTOR CONFIRMED THE UNCOMPLETED STAPLE LINE: A PART OF STAPLES WERE NOT FIRED ON THE TISSUE AND LATER FOUND EVEN STAPLES FIXED ON THE TISSUE WAS EASILY DETACHED. MALFORMATION OF STAPLES WAS OBSERVED. USING ANOTHER DEVICE OR TRISTAPLE PRODUCT TYPE FOR RECOVERY, THE STAPLE LINE WAS REINFORCED TO COMPLETE THE CASE WITH NO PROBLEM. NO PATIENT HARM. OPERATING TIME EXTENDED: LESS THAN 30 MIN. ADDITIONAL TISSUE RESECTION: YES. TISSUE DAMAGE: YES. NOTHING FELL INTO THE CAVITY. OZZING BLEEDING. NO INFO OF LOT # IS AVAILABLE. IN CASE LOT# IS IDENTIFIED AFTER ARRIVAL OF SAMPLE, I WILL ADD IT ON CTS. CONFIRMED THAT THE CLINICAL SAMPLE IS BEING RETURNED FOR INVESTIGATIONS. WHEN IT IS RETURNED TO THE INVESTIGATOR OF MANUFACTURER: UNK. NOTHING OF ADVERSE EVENT CAUSED BY EXTENSION OF OPERATION ROOM TIME WAS REPORTED. "NO PATIENT INFO IS AVAILABLE. GENDER: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444315 GIA 100-3.8 SINGLE USE RELOADABLE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other