BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 12314420 · Received August 12, 2021

    Report

    Report Number
    3005075853-2021-04676
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    November 28, 2020
    Report Date
    July 14, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2020. BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: WAS THERE ANY OTHER ISSUE NOTED WITH THE STAPLE LINE OTHER THAN BLEEDING (MALFORMED STAPLES, STAPLE LINE MISSING STAPLES, ETC.)? HOW WAS THE BLEEDING CONTROLLED? HOW MUCH BLOOD WAS LOST (ML)? DID THE PATIENT REQUIRE A TRANSFUSION? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.) BLOOD TRANSFUSION ON POST OP DAY 1 POST DISCHARGE (READMITTED DAY OF DISCHARGE AFTER SYNCOPAL EVENT AT HOME). NO SEQUALAE OR INTERVENTION AFTER TRANSFUSION. STAPLE LINE WAS HEMOSTATIC INTRA OP WITH TISSEAL NO CLIPS. NO MALFORMED STAPLES OR BLOOD LOSS AT TIME OF SURGERY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: INCREASED STAPLE LOADING PRESSURES AND REDUCED STAPLE HEIGHTS IN LAPAROSCOPIC SLEEVE GASTRECTOMY REDUCE INTRAOPERATIVE BLEEDING. AUTHOR/S: EUJIN YEO,MD JONATHAN THOMPSON,MD DENNIS HANSEMAN,PHD ADAM DUNKI-JACOBS,BS BEN THOMPSON,BS MICHAEL GOODMAN,MD TAYYAB DIWAN,MD CITATION: HTTPS://DOI.ORG/10.1016/J.SURG.2020.10.045. THIS STUDY AIMED TO FIRST, TO INDIRECTLY MEASURE THE COMPRESSIVE PRESSURE THE AVERAGE STAPLE APPLIES TO TISSUE AND SECOND, TO DEVELOP AND EVALUATE THE CLINICAL OUTCOMES OF A DATA-DRIVEN STAPLE CARTRIDGE SELECTION ALGORITHM BASED ON THAT PRESSURE. A TOTAL OF 116 PATIENTS UNDERGOING LAPAROSCOPIC SLEEVE GASTRECTOMY WERE INCLUDED. LSGS WERE PERFORMED BY THE 2 SURGEONS PER STANDARD PRACTICE USING A 60-MM ECHELON FLEX POWERED PLUS STAPLER WITH GST STAPLE. RELOADS (ETHICON, INC). THEIR STANDARD PRACTICE FOR INTRAOPERATIVE STAPLE CARTRIDGE SELECTION, TYPICALLY GREEN-BLUE-BLUE-BLUE WITH ROOM FOR DEVIATIONS, WAS USED TO DEFINE STAPLING PROTOCOL 1 (SP1). THE NEXT 52 CASES WERE PERFORMED UNDER STAPLING PROTOCOL 2 (SP2), WHICH TYPICALLY CONSISTED OF CARTRIDGE SEQUENCES OF BLUE-BLUE-WHITE-WHITE FOR ONE SURGEON AND GOLD-BLUE-WHITE-WHITE FOR THE OTHER, ALLOWING FOR INTRAOPERATIVE DEVIATIONS. ALL OTHER ASPECTS OF LSG REMAINED UNCHANGED. DATA ON INTRAOPERATIVE BLEEDING RATES BY CARTRIDGE ZONE AND HEMOSTATIC TECHNIQUES USED WERE DERIVED FROM DEIDENTIFIED VIDEO RECORDINGS FOR 52 CASES. INTRAOPERATIVE BLEEDING WAS DEFINED AS ANY VISIBLE BLEEDING ALONG THE STAPLE LINE. IN ADDITION, 30-DAY POSTOPERATIVE BLEEDING AND LEAK DATA WERE COLLECTED FOR ALL CASES IN SP1 AND SP2. TISSUE THICKNESS MEASUREMENTS FROM 39 CASES AND STAPLE LOAD SELECTION SHOWED THAT SURGEONS PREFERRED A MEDIAN STAPLE LOADING PRESSURE OF 15 G/MM2. TISSUE THICKNESS MEASUREMENTS AT 15 G/MM2 HAD A MEAN OF 1.86 MM AT THE ANTRUM, 1.71 MM AT THE BODY, AND 1.15 MM AT THE FUNDUS, ALL SIGNIFICANTLY THINNER THAN TISSUE THICKNESS AT 8 G/MM2. FOR EACH 10 G/MM2 INCREASE IN MINIMUM PRESSURE AND MAXIMUM PRESSURE VALUE WITHIN EACH CARTRIDGE ZONE, THERE WAS A REDUCTION IN BLEEDING RATE BY 59.8% AND 38.7%, RESPECTIVELY. COMPARED WITH STAPLING PROTOCOL 1, STAPLING PROTOCOL 2 HAD A LOWER INTRAOPERATIVE BLEEDING RATE (90.2% VS 70.7%; P < .0001), USAGE OF PREVENTIVE HEMOSTATIC TECHNIQUES (100% VS 10%; P <.0001), AND HEMOSTATIC TREATMENTS (66% VS 46%; P ¼.04). IN THE 30-DAY POSTOPERATIVE PERIOD, THERE WAS 1 BLEED IN STAPLING PROTOCOL 1; THERE WERE NO LEAKS. REPORTED 30-DAY POSTOPERATIVE COMPLICATION INCLUDED N=1 BLEEDING. IN CONCLUSION, OUR EXPERIENCE DEMONSTRATES THAT THE USE OF HIGHER LOADING PRESSURES AND SHORTER CLOSED STAPLE HEIGHT (CSHS) IN LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) IS NOT ONLY BIOMECHANICALLY ACCEPTABLE BUT ALSO YIELDS BETTER TISSUE APPOSITION. WE SHOW THAT BY USING STAPLE CARTRIDGES WITH SHORTER CSHS WE CAN REDUCE BOTH INTRAOPERATIVE BLEEDING AND HEMOSTATIC TECHNIQUES USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210222 ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention