BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1823645 · Received November 16, 2007

    Report

    Report Number
    1527736-2007-07786
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    October 30, 2007
    Report Date
    October 31, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE DEVICE ONLY STAPLED ONE SIDE. PATIENT LOST BLOOD FROM THE SIDE OF THE INNER VEIN. ADDITIONAL SUTURE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    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. (CINCINNATI) NA D4HT53

    Patients

    Seq Age Sex Outcome Treatment
    1