BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1003649 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00885
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 22, 2008
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT THORACOSCOPY WITH WEDGE RESECTION PROCEDURE, THE DEVICE DID NOT STAPLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35MM GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JT1R

    Patients

    Seq Age Sex Outcome Treatment
    1