BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45

    MDR report key: 2082006 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01859
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    April 13, 2011
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. EES TEAM SPOKE WITH DR. DR. HAS BEEN USING THE PLATFORM FOR 12 YEARS, APPROXIMATELY 2500-3000 GASTRIC BYPASSES PER YEAR, UTILIZING ETS PLATFORM IN 97% OF THE CASES. DR. INDICATED POOR PERFORMANCE. HE BELIEVED THAT MUCH MORE OF THE STAPLES DID NOT HAVE A NEATLY SEALED STAPLE LINE. THE PROPHYLAXIS REGIMENS DID CHANGE IN (B)(4) 2011. THE PATIENT EXHIBITED A (B)(6) WITH NORMAL TISSUE CONDITION. DR. METICULOUSLY CLEANS EACH DEVICE HIMSELF IN BETWEEN FIRINGS AND CHANGES THE CARTRIDGES HIMSELF. DR. FELT THAT THE DEVICE WAS "DODGY" FROM THE BEGINNING. APPEARS THAT THE STAPLE LINES ARE NOT SEALED. DR. IS CURRENTLY USING THE ECHELON PLATFORM WITH NO DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SURGEON SAW A LOT OF STAPLE LINES WHICH WERE "DODGY" AND SEVERAL STAPLES FALLING OFF FROM NORMAL STAPLE LINES. IT APPEARED THAT THE INNERMOST STAPLE LINE ALMOST IS NOT INCLUDED IN THE TISSUE OR RIPPED OUT WHEN CUTTING. THE CUSTOMER DISPOSED OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1