BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 45 STANDARD

    MDR report key: 9503571 · Received December 20, 2019

    Report

    Report Number
    3005075853-2019-24638
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 5, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001676
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). DATE SENT: 1/21/2020. H1: MDR DECISION: NOT REPORTABLE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON/AUTHOR BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. WE DO NOT BELIEVE THAT THERE IS ANY CAUSAL LINK TO THE EQUIPMENT AND INSTRUMENTS USED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE UNK. 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 SURGEON/AUTHOR 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 VIA JOURNAL ARTICLE TITLE: USE OF BARBED SUTURES IN ROBOTIC BARIATRIC BYPASS SURGERY: A SINGLE-CENTER CASE SERIES. AUTHORS: JAN HENRIK BECKMANN, JAN-NICLAS KERSEBAUM, WITIGO VON SCHÖNFELS, THOMAS BECKER, CLEMENS SCHAFMAYER AND JAN HENDRIK EGBERTS. CITATION: BMC SURGERY (2019) 19:97; DOI: HTTPS://DOI.ORG/10.1186/S12893-019-0563-Z. THIS UNCONTROLLED, SINGLE-CENTER, SINGLE-SURGEON CASE SERIES AIMED TO DETERMINE WHETHER BARBED SUTURES CAN BE USED SAFELY IN ROBOTIC ROUX-EN-Y BYPASS (RYGB) SURGERY. FROM AUG2017 TO SEP2018, 50 RYGB PROCEDURES WITH THE DA VINCI XI SURGICAL SYSTEM USING UNIDIRECTIONAL BARBED SUTURES WERE PERFORMED. IN THE PROCEDURE, THE SIDE-TO-SIDE GASTROJEJUNOSTOMY WAS PERFORMED WITH A LINEAR STAPLER (ECHELON FLEX 45 (GOLD CARTRIDGE) AND THE ENTEROTOMY WAS CLOSED USING A CONTINUOUS SEROMUSCULAR SUTURE FROM EACH CORNER, STARTING WITH A 15 CM, UNIDIRECTIONAL 2-0 STRATAFIX THREAD. PROXIMAL TO THE ANASTOMOSIS, THE SMALL INTESTINE WAS SEPARATED WITH THE SAME ECHELON FLEX 45 MM (BLUE CARTRIDGE). A SIDE-TO-SIDE LINEAR STAPLED JEJUNOJEJUNOSTOMY WAS CREATED, AGAIN USING THE 45MM LINEAR STAPLER (BLUE CARTRIDGE). THE ENTEROTOMY WAS CLOSED BY A SINGLE RUNNING SUTURE WITH STRATAFIX 3¿0. NO COMPLICATIONS OCCURRED INTRAOPERATIVELY. THE RUNNING SUTURES FOR CLOSING THE ENTEROTOMY WERE PERFORMED WITHOUT ANY PROBLEMS IN ALL CASES. IN ONE CASE, WITH CHRONIC FISTULA OF THE PROXIMAL STAPLE LINE 14 MONTHS AFTER SLEEVE GASTRECTOMY, THE INDICATION FOR RECONSTRUCTION INTO A PROXIMAL BYPASS WAS GIVEN. THE OPERATION AND FURTHER COURSE WERE WITHOUT ANY PROBLEMS. IN ANOTHER CASE, A PARTIAL OMENTUM NECROSIS WITH ABNORMAL INFECTION PARAMETERS WAS NOTED REQUIRING REVISION OPERATION. THIS PATIENT WAS DISCHARGED ON THE EIGHTH POSTOPERATIVE DAY WITHOUT FURTHER COMPLICATIONS. FURTHERMORE, ONE PATIENT DEVELOPED GASTROINTESTINAL BLEEDING IN WHICH GASTROSCOPY SHOWED AN ULCER IN THE ANASTOMOSIS AREA WITHOUT ACTIVE BLEEDING. NO FURTHER BLEEDING OCCURRED UNDER CONSERVATIVE THERAPY AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT WAS DISCHARGED AFTER FIVE DAYS AND NO MORE COMPLAINTS WERE REPORTED. IN THE ARTICLE, NECROSIS WAS NOT RELATED TO THE SELECTED SUTURE MATERIAL OR THE USE OF THE DA VINCI SURGICAL SYSTEM. WE FOUND THAT THE USE OF SELF-FIXING BARBED SUTURES IN ROBOTIC RYGB IS SAFE. THE SELF-FIXING SUTURE ENABLES THE ROBOTIC SURGEON TO PERFORM A SIMPLE CONTINUOUS SUTURE WITHOUT THE NEED FOR RECURRENT RETRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298701 ECHELON FLEX 45 STANDARD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. EC45A 10705036001676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention