BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 4093253 · Received September 16, 2014

    Report

    Report Number
    3005075853-2014-06442
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID THE DEVICE DELIVER ANY STAPLES? IF YES, WERE THE STAPLES FORMED PROPERLY? IF YES, WAS THE STAPLE LINE COMPLETE? WAS THERE ANY DAMAGE ON THE DEVICE OR JAWS? WHAT COLOR CARTRIDGE WAS BEING USED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE ENDOCUTTER WORKS FINE THE FIRST SHOTS. IN THE FOURTH SHOT DURING THE ACTIVATION THE SURGEON REPORTED DIFFICULTY IN OPENING OF THE JAWS OF THE CLAMP DEVICE IS MALFORMED, DOES NOT CUT THE TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571404 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DT69

    Patients

    Seq Age Sex Outcome Treatment
    1