BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RELOAD FOR ECHELON 60

    MDR report key: 12309281 · Received August 11, 2021

    Report

    Report Number
    3005075853-2021-04651
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    January 1, 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
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/26/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. ANSWER =THE TECHNICAL PROBLEMS THAT MENTIONED IN OUR ARTICLE ARE NOT RELATED TO THE STAPLER MALFUNCTION OR PRODUCTION. I PERSONALLY DID NOT HAVE ANY PROBLEM WITH THE STAPLERS. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE. B1, H1 & H6.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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 REVIEW OF JOURNAL ARTICLE, TITLE: CLINICAL FEATURES AND SHORT-TERM OUTCOMES OF BARIATRIC SURGERY IN MORBIDLY OBESE PATIENTS: INSTITUTIONAL EXPERIENCE AT A RURAL HOSPITAL. AUTHORS: KAZIM SENOL, MD, MURAT FERHAT FERHATOGLU, MD, AYSEN AKKURT KOCAELI, MD, HALIT ZIYA DUNDAR, MD, AND EKREM KAYA, MD. CITATION:BARIATRIC SURGICAL PRACTICE AND PATIENT CARE VOLUME 16, NUMBER 1, 2021 MARY ANN LIEBERT, INC. DOI: 10.1089/BARI.2020.0110. THE OBJECTIVES WAS TO PROSPECTIVELY EVALUATE THE POSTOPERATIVE MORBIDITY, MORTALITY, AND WEIGHT LOSS EVOLUTION OF PATIENTS WHO UNDERWENT A BARIATRIC PROCEDURE DURING 1 YEAR OF FOLLOW-UP. SINCE JULY 2016, A TOTAL OF 101 PATIENTS¿ DATA HAVE BEEN PROSPECTIVELY REGISTERED IN A DATABASE. COMORBIDITIES, OPERATING TIME, HOSPITAL STAY, EARLY AND LATE COMPLICATIONS RATE, AND WEIGHT LOSS EVOLUTION AFTER 1 YEAR OF FOLLOW-UP WERE RECORDED. ALL PATIENTS WERE GIVEN CLEAR LIQUID DIETS BEFORE 2 WEEKS OF SURGERY. THE FIRST STEP TO PERFORM THE LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). THE FAT PAD ON THE GASTROESOPHAGEAL JUNCTION WAS ALSO DISSECTED AND REMOVED BEFORE TRANSECTION OF THE STOMACH. FOLLOWING THE GREAT CURVATURE¿S LIBERATION FROM THE OMENTUM, THE STOMACH WAS DIVIDED FROM THE ANTRUM TOWARD THE ANGLE OF HIS BY USING THE ECHELON FLEX LINEER CUTTER, 60MM LOADED WITH ECR60 CARTRIDGES (ETHICON ENDO-SURGERY).THE FIRST STEP TO PERFORM THE ROUX-EN-Y GASTRIC BYPASS (RNYGB) WAS TO DISSECT THE LEFT DIAPHRAGMATIC PILLAR WITH LIGASURE TO PREPARE THE GASTRIC POUCH. DISSECTION OF THE OMENTUM WAS ESSENTIAL TO IDENTIFY LESSER SAC, RETROGASTRIC SPACE, AND ANGLE OF HIS. THE FAT PAD ON THE ANTERIOR SURFACE OF THE STOMACH SHOULD ALSO BE REMOVED. THE STOMACH WAS TRANSECTED THROUGH THIS WINDOW WITH ECHELON FLEX LINEER CUTTER, 60MM LOADED WITH ECR60 GOLD CARTRIDGES BETWEEN TWO LANDMARKS 3¿4 CM BELOW THE ESOPHAGOGASTRIC JUNCTION ON THE LEFT SIDE AND ANGLE OF HIS ON THE RIGHT SIDE TO CREATE A 30¿ 40 CM3 GASTRIC POUCH. THE SECOND STEP WAS TO CREATE A JEJUNAL LOOP, THE ROUX LIMB OF THE RNYGB PROCEDURE, THE JEJUNAL SEGMENT 50 CM BELOW THE TREITZ WAS MARKED WITH A POLYGLACTIN VICRYL SUTURE (ETHICON). AN ECHELON FLEX LINEER CUTTER, 60MM LOADED WITH ECR60 GOLD CARTRIDGE (ETHICON ENDO-SURGERY), WAS INSERTED TO THE ABDOMEN FROM THE LEFT UPPER 12MM TROCAR, AND THE JEJUNAL LOOP WASMOBILIZED TO THE GASTRIC POUCH. THE ROUX LIMBOF THE PROCEDURE WAS SUTURED TO THE REMNANT STOMACH WITH ETHIBOND 2-0 SUTURES (ETHICON) TO AVOID FURTHER TWIST OF THE ANASTOMOSIS. THE THIRD STEP WAS THE ANASTOMOSIS OF THE PANCREATOBILIARY LIMB TO THE JEJUNUM DISTAL TO THE GASTROJEJUNOSTOMY ANASTOMOSIS. THE JEJUNUM WAS MEASURED 100 CM DISTAL TO THE GASTROJEJUNOSTOMY AND MOBILIZED CLOSE TO THE PANCREATOBILIARY LIMB. A SEROMUCOSAL FULL-THICKNESS CUT WAS PERFORMED WITH THE LIGASURE AT THE ANTERIOR SURFACES OF THE JEJUNAL SEGMENTS. AN ECHELON FLEX LINEER CUTTER, 60MM LOADED WITH ECR60 GOLD CARTRIDGE, WAS INSERTED TO THE ABDOMEN FROM THE LEFT UPPER 12MM TROCAR, AND ISOPERISTALTIC SIDE-TO-SIDE JEJUNOJEJUNOSTOMY WAS PERFORMED WITH THE STAPLING DEVICE. THE LAST STEP WAS ACHIEVED WITH THE STAPLING DEVICE BY TRANSECTING THE JEJUNUM BETWEEN GASTROJEJUNOSTOMY AND JEJUNOJEJUNOSTOMY LOOPS. THE PETERSEN MESENTERIC WINDOW WAS SUTURED WITH NONABSORBABLE 2-0 SILK SUTURES(ETHICON) CONTINUOUSLY. A 7MM SUCTION DRAIN WAS PLACED LATERALLY TO THE STAPLE LINE FROM THE LEFT QUADRANT 5MM TROCAR SITE. THE FASCIA OF THE 12MM PORT OPENINGS WAS CLOSED WITH 2/0 VICRYL SUTURES. REPORTED COMPLICATIONS INCLUDED STAPLER LINE LEAKAGE IN ONE LSG CASE AND ONE RNYGB CASE THAT OCCURRED IN EARLY FOLLOW-UP ON THE POSTOPERATIVE SECOND DAY, WERE PROVED WITH SWALLOW TEST, AND TREATED WITH INTRAGASTRIC STENTING THROUGH THE CONSERVATIVE APPROACH. ONE PATIENT WITH LSG WAS OPERATED ON THE FIFTH POSTOPERATIVE DAY OWING TO INITIAL METHYLENE-BLUE LEAKAGE INTO THE DRAIN CONSEQUENT TO FINDINGS OF ABDOMINAL DISCOMFORT, AND THE LEAKAGE LINE WAS ONE-LAYER SUTURED. IN CONCLUSION LSG AND RNYGB ARE SAFE AND HIGHLY EFFECTIVE, PARTICULARLY IN PATIENTS WITH A BMI >50 KG/M2. BOTH TECHNIQUES HAVE BEEN PRESENTED WITH BETTER CLINICAL OUTCOMES REGARDING SIGNIFICANT COMORBIDITY RESOLUTION IN THE EARLY EVOLUTION OF WEIGHT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203590 UNKNOWN RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1