BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1880076 · Received October 22, 2010

    Report

    Report Number
    3005075853-2010-06004
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 28, 2010
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INTERRUPTED/INCOMPLETE FIRING THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD IN THE DEVICE. THE RETURNED RELOAD WAS PARTIALLY FIRED WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, THE PRESSURE GAUGE BROKE. THE PHYSICIAN HAD THE PRESSURE ON THE ADVANTAGE INFLATION UNIT AT 16ATMS WHEN THE OUTER HOUSING OF THE PRESSURE GAUGE BROKE IN HALF AND EXPOSED THE GAUGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANTAGE INFLATION UNIT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE, THERE WAS AN INCOMPLETE STAPLE LINE, MALFORMED STAPLES, NO FURTHER INFORMATION IS AVAILABLE. ANOTHER 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
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TD3F

    Patients

    Seq Age Sex Outcome Treatment
    1