BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 14241188 · Received April 28, 2022

    Report

    Report Number
    3005075853-2022-02741
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    PMA / PMN Number
    K190937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED: WHAT WAS THE PATIENT¿S DIAGNOSIS AND INDICATIONS FOR THE SURGICAL PROCEDURE? WHAT ETHICON STAPLER DEVICE WAS USED? WHY DOES THE SURGEON ALLEGE A DEFICIENCY AGAINST THE BUTTRESSING MATERIAL CAUSED OR CONTRIBUTED TO THE BLEEDING? CAN YOU CLARIFY WHAT IS MEANT BY ¿PRESSURE REDUCING PIPE¿? DID THE PATIENT REQUIRE ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION? WHAT IS THE CURRENT PATIENT STATUS? THE DEVICE WAS PSEE60A. THE SALES REP COMMENTED THAT THE FORMATION OF THE STAPLES LOOKED FINE. THE SURGEON COMMENTED THAT THE SLR WAS STIFF. LEAKAGE WAS NOT A MAJOR LEAK. THE PATIENT¿S CONDITION IS STABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING DOCUMENTATION COULD NOT BE COMPLETED AS THE LOT WAS NOT PROVIDED. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/17/2022. ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING WAS RECEIVED: DID THE PATIENT REQUIRE ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY FOR OBESITY, THE DEVICE WITH A BLACK CARTRIDGE WAS FIRED AT THE 1ST FIRING. THE DEVICE WITH A GOLD CARTRIDGE WAS FIRED FROM 2ND TO 5TH FIRING. LASTLY THE DEVICE WITH A BLACK CARTRIDGE WAS FIRED TWICE ON THE LOWER GREATER CURVATURE OF STOMACH, BUT THEN OOZING WAS OBSERVED. ADDITION SUTURE WAS PERFORMED WITH A VICRYL TO REINFORCE THE TISSUE. THE SLR WAS USED FOR ALL THE FIRINGS. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. ON APRIL 5TH, CT WAS TAKEN, AND IT WAS FOUND THAT ANOTHER OOZING WAS CONFIRMED WHERE THE DEVICE WAS FIRED AT 4TH AND 5TH FIRING. IT DID NOT REACH TO THE TUMOR BUT LEAKAGE WAS SEEN LIKE A BUBBLE IN CT. THE AMOUNT OF BLEEDING IS UNKNOWN. NO TRANSFUSION WAS PERFORMED. CRP WAS HIGH. THE SURGEON COMMENTED THAT THERE IS A POSSIBILITY THAT THIS OOZING OCCURRED FROM THE 1ST OOZING. A PRESSURE REDUCING PIPE WAS PLACED IN THE STOMACH AND THE PATIENT ABSTAINED FROM FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214138 ECHELON 60MM REINFORCEMENT OXC OXC ETHICON ENDO-SURGERY, LLC. ECH60R 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GST60D| GST60T| POWERED 60 ECHELON +, 340MM SHAFT