BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    MDR report key: 1021964 · Received March 11, 2008

    Report

    Report Number
    1527736-2008-01483
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/11/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN LOBECTOMY THORACIC PROCEDURE, AFTER SEVERAL FIRINGS THE DEVICE WAS PLACED ON THE PULMONARY ARTERY AND FIRED, BUT WHEN TRYING TO RELEASE THE DEVICE, IT WAS NOTICED THE ARTICULATING JOINT HAD SEPARATED FROM THE SHAFT OF THE DEVICE PREVENTING IT FROM OPENING. ANOTHER DEVICE WAS PLACED PROXIMAL TO THE STAPLER AND FIRED IN ORDER TO REMOVE THE LOCKED DEVICE ALONG WITH THE SPECIMEN. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM GDW ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention