BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45

    MDR report key: 2081881 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01856
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 12, 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). THE ANALYSIS RESULTS FOUND THAT FOUR ETS45 DEVICES WERE RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOADS LOADED IN THE DEVICES. THE RELOADS WERE RECEIVED FULLY FIRED. AFTER FURTHER EVALUATION SEVERAL B-FORM STAPLES WERE NOTED TO BE INSIDE THE JAWS OF THE DEVICE. IT SHOULD BE NOTED THAT PRIOR TO RELOADING THE INSTRUMENT, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE INSTRUMENT. DO NOT USE THE INSTRUMENT UNTIL IT HAS BEEN VISUALLY INSPECTED TO CONFIRM THERE ARE NO STAPLES ON THE ANVIL AND CARTRIDGE JAW. THE DEVICES WERE TESTED FOR FUNCTIONALITY USING TEST MEDIA AND WITH TEST RELOADS. THE DEVICES FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICES FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINES WERE COMPLETE, THE CUT LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IN ADDITION THE DEVICES WERE TESTED ON GASTRIC TISSUE MEASURE AT 1.5MM THICKNESS AND ALSO WERE FIRED ON JEJUNUM. NO ABNORMALITIES WERE NOTED DURING THE TISSUE TESTING OF THE DEVICE, ALL STAPLE FORMED PROPER B-SHAPE AND STALE LINES WERE NOTED TO BE COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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)(6) 2011. THE PATIENT EXHIBITED A BMI BETWEEN (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 WAS VERY SURE THAT THERE WAS A CLEAN STAPLE AND WHEN MAKING THE LAST SEPARATION OF SMALL BOWEL THE STAPLE "TRASHED" THE EDGES AND SOME STAPLES CAME OUT. THE SURGEON HAD TO OVER SEW THE STAPLE LINES AND THE PATIENT IS DOING FINE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    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