BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 8686285 · Received June 11, 2019

    Report

    Report Number
    3005075853-2019-19627
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    May 14, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE - BATCH # UNK. 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. 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: INTRAOPERATIVE PATTERNS OF GASTRIC MICROPERFUSION DURING LAPAROSCOPIC SLEEVE GASTRECTOMY. AUTHORS: TARIK DELKO, HENRY HOFFMANN, MARKO KRALJEVIC, RAOUL A. DROESER, LINCOLN ROTHWELL, DANIEL OERTLI AND URS ZINGG. CITATION: OBES SURG (2017) 27:926¿932; DOI 10.1007/S11695-016-2386-7. THIS STUDY AIMED TO ASSESS THE REAL-TIME INTRAOPERATIVE GASTRIC MICROPERFUSION PATTERNS OF THE STOMACH DURING LSG USING VISIBLE LIGHT SPECTROSCOPY (VLS). IN 2014, 20 PATIENTS (WITH MEAN AGE 42.9 YEARS MALE N=3, FEMALE N=17) UNDERGOING LSG AT THE DEPARTMENT OF SURGERY, UNIVERSITY HOSPITAL (B)(6), PARTICIPATED IN THE STUDY. AFTER COMPLETE MOBILIZATION OF THE GREATER CURVATURE STARTING 3 CM FROM THE PYLORUS, THE TUBE WAS INTRODUCED AND LSG WAS PERFORMED USING AN ECHELON FLEX POWERED ENDOPATH (ETHICON INC, (B)(6), USA) STAPLER WITH 60-MM GREEN RELOADS FOR THE ANTRUM AND BODY AND 60-MM BLUE RELOADS FOR THE FUNDUS TAKING THE VARIABLE WALL THICKNESS OF THE DIFFERENT ANATOMICAL AREAS OF THE STOMACH INTO CONSIDERATION. HEMOSTATIC CONTROL WAS ACHIEVED BY USING MONOPOLAR DIATHERMY OR 3-0 PDS (ETHICON INC, (B)(6), USA) SUTURES. COMPLICATION INCLUDED POSTOPERATIVE BLEED (N=1) THAT REQUIRED A BLOOD TRANSFUSION AND MONITORING IN THE INTENSIVE CARE UNIT. IN CONCLUSION, ASSESSMENT OF MICROPERFUSION PATTERNS OF THE STOMACH DURING LSG USING VLS IS SAFE AND EFFICACIOUS TO USE ALLOWING AN ACCURATE MEASUREMENT OF STO2%. THE UPPER THIRD OF THE STOMACH IS THE ZONE OF REDUCED MICROPERFUSION WITH A SIGNIFICANT DROP OF TISSUE OXYGENATION AFTER SLEEVE RESECTION OF THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482352 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