BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER

    MDR report key: 45423 · Received October 21, 1996

    Report

    Report Number
    1527736-1996-00298
    Event Type
    Malfunction
    Date Received
    October 21, 1996
    Date of Event
    September 23, 1996
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D5, H4-INFO UNAVAILABLE, DEVICE RETURNED WITH NO LOT IDENTIFICATION.

    Description of Event or Problem · 1

    10/02/96 THE SURGEON RESPONDED TO THE NNCL. HE STATED THE INSTRUMENT WOULD NOT FIRE. HE GRABBED THE LUNG TISSUE, PLACED THE INSTRUMENT, AND FIRED. IT DID NOT CUT. HE COULD NOT REMEMBER IF THE DEVICES STAPLED OR NOT. ANOTHER INSTRUMENT WAS OPENED TO COMPLETE THE CASE. KJB

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO SURGERY, INC. NA H40M12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other