BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ETS45

    MDR report key: 2081996 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01857
    Event Type
    Injury
    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
    Adverse Event
    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)(6) 2011. THE PATIENT EXHIBITED A (B)(6) WITH NORMAL TISSUE CONDITION. THE PATIENT WAS A MALE, TYPE 1 DIABETIC; HE WAS A LARGE MAN, VERY THICK. POST OP DAY 1 EXPERIENCED TACHYCARDIA AND RETURNED TO THE THEATRE. THE POUCH WAS LEAKING FROM TWO SIDES (LAST CARTRIDGE A THE ANGLE OF HISS). HE COULD NOT SAY WITH 100% BUT BELIEVED IT TO BE CLEAN AT CLOSURE. HE PERFORMED A BLUE DYE TEST AND NO LEAK WAS PRESENT. THE PATIENT WAS OVER SUTURED ON NOW WELL AND ON HIS WAY BACK HOME TO (B)(6). 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 HAD A LEAK LAST WEEK AT IMPERIAL FROM A VERTICAL STAPLE LINE OF THE POUCH IN A VERY HIGH RISK GASTRIC BYPASS (TYPE 1 DIABETES, 3 PREVIOUS MI, ETC). THE LEAK WAS CLEARLY FROM THE STAPLE LINE. THE PATIENT IS STILL IN THE HOSPITAL. THE SURGEON SURGICALLY MANAGED BY SUTURE AND DRAINS. THE PATIENT HAD ANOTHER MI THE DAY AFTER THE OPERATION AND ATRIAL FIBRILLATION. HOWEVER, THE PATIENT SEEMS TO BE RECOVERING WELL. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention