BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 12310771 · Received August 11, 2021

    Report

    Report Number
    3005075853-2021-04663
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    May 3, 2021
    Report Date
    July 13, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. PUBLICATION DATE IS MAY 3, 2021. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS. THE LOT/ BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION: DOES THE AUTHOR/ SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVIEW OF JOURNAL ARTICLE, TITLE: IMPACTS OF GASTROJEJUNAL ANASTOMOTIC TECHNIQUE ON RATES OF MARGINAL ULCER FORMATION AND ANASTOMOTIC BLEEDING FOLLOWING ROUX-EN-Y GASTRIC BYPASS. AUTHORS: NARESH SUNDARESAN, MARIEL SULLIVAN, B. AMY HITICAS, BENEDICT Y. HUI, LAUREN POLIAKIN, KYLE J. THOMPSON, IAIN H. MCKILLOP, SELWAN BARBAT, TIMOTHY S. KUWADA, KEITH S. GERSIN, ABDELRAHMAN NIMERI. CITATION: OBESITY SURGERY (2021) 31:2921¿2926, HTTPS://DOI.ORG/10.1007/S11695-021-05292-2. THE OBJECTIVES OF THIS STUDY WAS TO ANALYZE THE INCIDENCE OF MU AND BLEEDING BETWEEN THE 25-MM END-TO-END ANASTOMOSIS (EEA) STAPLER, LINEAR STAPLER (LS), AND ROBOTIC HAND-SEWN (RHS) GJA TECHNIQUES. A TOTAL OF 1112 PATIENTS UNDERWENT ROUX-EN-Y GASTRIC BYPASS BETWEEN 2010 AND 2014. OF THESE PATIENTS, 652 (58.6%) HAD A GJA PERFORMED VIA AN EEA CIRCULAR STAPLER,374 (33.6%) HAD A GJA PERFORMED VIA A LINEAR STAPLED APPROACH, AND 86 (7.7%) HAD A GJA PERFORMED WITH A ROBOTIC HAND-SEWN APPROACH. OUT OF ALL PATIENTS, 194/1,112 (17.4%) UNDERWENT AN UPPER ENDOSCOPY. END-TO-END ANASTOMOSIS (EEA) A 25-MM EEA STAPLER WAS USED TO CREATE THE GJA, AND ONE OF THE TWO METHODS FOR INTRODUCING THE ANVIL WAS EMPLOYED: INTRODUCTION VIA A SEPARATE GASTROTOMY PRIOR TO CREATING THE POUCH OR INTRODUCTION USING AN OROGASTRIC TUBE. THE STAPLER WAS INTRODUCED VIA AN ENTEROTOMY IN THE ROUX LIMB, WITH THE SPIKE DEPLOYED THROUGH THE SIDEWALL OF THE ROUX LIMB SMALL BOWEL AND SUBSEQUENTLY JOINED WITH THE ANVIL IN THE GASTRIC POUCH (THE GASTRIC POUCH REMAINED APPROXIMATELY 30CC IN SIZE). THE ROUX-LIMB OVERHANG WAS THEN REMOVED USING AN ECHELON 60-MM BLUE LINEAR STAPLE LOAD (ETHICON) SUCH THAT THE TIP OF THE ROUX LIMB WAS POINTING TOWARD THE RIGHT SIDE OF THE PATIENT. LINEAR STAPLER (LS) AN ECHELON 45-MM STAPLER BLUE LOAD (ETHICON) WAS USED TO CREATE THE GJA WITH THE STAPLE LINE MEASURING APPROXIMATELY 2.5CM, AND THE COMMON GASTROTOMY/ENTEROTOMY WAS CLOSED USING A 2-0 VICRYL SUTURE(ETHICON). THE ROUX-LIMB OVERHANG WAS THEN REMOVED USING AN ECHELON 60-MM BLUE LINEAR STAPLE LOAD SUCH THAT THE TIP OF THE ROUX LIMB WAS POINTING TOWARD THE LEFT SIDE OF THE PATIENT. ROBOTIC HAND SEWN (RHS) A 30-CC GASTRIC POUCH WAS CREATED USING A LINEAR STAPLER AND A GASTROTOMY AND ENTEROTOMY MADE. A TWO-LAYERED HAND-SEWN GJA WAS THEN CREATED USING 2-0 VICRYL SUTURES (ETHICON) FOR THE ANTERIOR/ POSTERIOR OUTER LAYERS AND A RUNNING 3-0 MONOCRYL SUTURE (ETHICON) FOR THE INNER LAYERS. REPORTED COMPLICATIONS INCLUDED MARGINAL ULCERS, BLEEDING, PERFORATION OF THE GASTROJEJUNAL ANASTOMOTIC. IN CONCLUSION THE METHOD OF GJA HAS AN IMPACT ON RATE OF MU FORMATION. A GJA FASHIONED WITH A 25-MM EEA STAPLER TENDS TO HAVE HIGHER RATES OF EGD AND MU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207256 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention