BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 18332850 · Received December 14, 2023

    Report

    Report Number
    3005075853-2023-09440
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    August 1, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/14/2023. B3: PUBLICATION YEAR OF 2023. D4: BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    TITLE: LAPAROSCOPIC SLEEVE GASTRECTOMY WITH TRANSIT LOOP BIPARTITION AND TRANSIT BIPARTITION IN TYPE 2 DIABETIC PATIENTS WITH OBESITY: A RETROSPECTIVE ANALYSIS AUTHORS: CANAN DEMIR, MD,* ERGIN ARSLAN, MD,¿ GÜLÇIN SARIYILDIZ, MD,¿ CÜNEYD ANIL, MD,§ AND OKTAY BANLI, MD¿ CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH 2023;33(4):357¿364. WWW.SURGICAL-LAPAROSCOPY.COM. THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE 1-YEAR POSTOPERATIVE RESULTS OF PATIENTS WITH OBESITY AND TYPE 2 DIABETES MELLITUS (T2DM) WHO UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY WITH TRANSIT BIPARTITION (LSG-TB) AND TRANSIT LOOP BIPARTITION (LSG-TLB) AND MINI GASTRIC BYPASS (MGB). BETWEEN (B)(6) 2017 AND (B)(6) 2021, PATIENTS WITH T2DM WITH OBESITY WHO UNDERWENT EITHER LSG-TLB, LSGTB, OR MGB, WERE INCLUDED IN THE STUDY. OVERALL, 32 PATIENTS (15 MALE AND 17 FEMALE; MEAN AGE WAS 48.8±6.7 YEARS) UNDERWENT THE LSG-TLB PROCEDURE, 15 PATIENTS (6 MALE AND 9 FEMALE; MEAN AGE WAS 51.2±5.6 YEARS) UNDERWENT LSG-TB, AND 50 PATIENTS (17 MALE AND 33 FEMALE; MEAN AGE WAS 49.9±8.5 YEARS) HAD MGB. A LINEAR STAPLER (ECHELON 60 ENDOPATH STAPLER AND CUTTER, 60 MM; ETHICON) WAS USED IN BOTH LSG-TLB AND LSG-TB PROCEDURE. IN MGB PROCEDURE, ULTRACISION (ETHICON ENDO-SURGERY) AND LINEAR ROTICULATOR STAPLER (ECHELON, ETHICON ENDO-SURGERY) WERE USED, AND AN ANTECOLIC SIDE-TO-SIDE GASTROJEJUNOSTOMY ANASTOMOSIS IS MADE USING A 45 MM CARTRIDGE AND THE ANASTOMOTIC OPENING IS CLOSED OVER A DOUBLE LAYER USING A 3/0 VICRYL OR V-LOCK SUTURE. REPORTED COMPLICATIONS INCLUDE PERSISTENT GASTROESOPHAGEAL REFLUX (N=1), MALABSORPTION (N=2) IN LSG-TLB GROUP, AND IRON AND VITAMIN D MALABSORPTION RESISTANT TO REPLACEMENT THERAPIES IN LSG-TB GROUP (N=1). IN CONCLUSION, LSG-TLB TOOK LESS TIME AND PROVIDED SIGNIFICANTLY HIGHER EXCESS BMI LOSS COMPARED WITH LSG-TB. T2DM REMISSION AND IMPROVEMENT RATES WERE SIMILAR IN BOTH GROUPS. LSG-TLB SEEMED LIKE A PROMISING BARIATRIC SURGERY TECHNIQUE IN PATIENTS WITH OBESITY AND T2DM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303514 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention