BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 8686900 · Received June 11, 2019

    Report

    Report Number
    3005075853-2019-19633
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    May 14, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? THE ANSWER TO YOUR QUESTION IS : NO.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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: GASTRIC WALL THICKNESS AND THE CHOICE OF LINEAR STAPLES IN LAPAROSCOPIC SLEEVE GASTRECTOMY: CHALLENGING CONVENTIONAL CONCEPTS AUTHORS: YASMIN ABU-GHANEM, CHANAN MEYDAN, LIOR SEGEV, MOSHE RUBIN, ORIT BLUMENFELD, HADAR SPIVAK CITATION: OBES SURG (2017); 27:837¿843. DOI: 10.1007/S11695-016-2516-2. THE OBJECTIVES OF THIS STUDY WERE TO DOCUMENT THE FEASIBILITY AND OUTCOMES OF ¿TIGHT¿ CLOSED STAPLE HEIGHT (CSH) TO TISSUE THICKNESS (TT) RATIO ON DIFFERENT SEGMENTS OF GASTRIC WALL IN LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG), IN ADDITION TO RE-VISITING MEASUREMENTS OF GASTRIC WALL TT, WITH THE NOVELTY OF INCLUDING THE PRE-PYLORIC AREA. THIS STUDY INCLUDES A PROSPECTIVELY COLLECTED OUTCOMES ON 202 CONSECUTIVE PATIENTS (55 MALE AND 147 FEMALE; AGE RANGE: 18-69 YEARS; BMI: 35-59.8 KG/M2) WHO UNDERWENT LSG WITH TIGHT ORDER OF STAPLES (ETHICON) IN THIS ORDER: PRE-PYLORUS¿BLACK (CSH = 2.3 MM), ANTRUM¿GREEN (CSH = 2.0 MM), ANTRUM/ BODY¿BLUE (CSH = 1.5 MM), AND WHITE (CSH = 1.0 MM) ON THE BODY AND FUNDUS. GASTRIC DIVISION WAS INITIATED AS CLOSE TO THE PYLORUS AS POSSIBLE (TYPICALLY 1¿2 CM FROM THE PYLORUS) AND ENDED AT THE ANGLE OF HIS. THE AUTHORS USED ECHELON FLEX ENDOPATH (ETHICON) LINEAR STAPLER CARTRIDGES OF 60 MM LENGTH. ALL LAPAROSCOPIC TROCAR ENTRY SITES WERE INSPECTED FOR BLEEDING AND WERE SEALED AS NEEDED USING ENDO CLOSE WITH 2-0 VICRYL SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED STAPLE-RELATED MECHANICAL FAILURES (N-34); SPLITTING OF THE SERO-MASCULAR LAYER (N-?) AND STAPLE LINE HEMATOMA (N-?) IN WHICH ALL OF THESE CONDITIONS WERE RESOLVED BY OVER SUTURING THE STAPLE-LINE WITH ABSORBABLE SUTURE, KINK AT THE UPPER ASPECT OF THE SLEEVE CAUSING NEAR-COMPLETE GASTRIC OBSTRUCTION (N-1) IN WHICH THE PATIENT WENT THROUGH UNEVENTFUL LAPAROSCOPIC CONVERSION OPERATION TO ROUX-EN-Y GASTRIC BYPASS ON THE 5TH WEEK POST LSG, WOUND INFECTION (N-1) THAT REQUIRED INCISION AND DRAINAGE AT THE SITE WERE THE GASTRIC SPECIMEN WAS EXTRACTED DURING LSG, AND INTRAPERITONEAL BLEEDING (N-5) IN WHICH THE PATIENTS RECEIVED A TOTAL 8 UNITS OF RED BLOOD CELLS AND 8 UNITS OF PLASMA, 1 WAS RE-EXPLORED IN THE OPERATION ROOM TO CONTROL THE BLEEDING FROM THE STAPLE LINE (MIDDLE ASPECT) AND 1 FOR DRAINAGE OF SPLENIC HILUM HEMATOMA. IN CONCLUSION, THE STUDY SUGGESTS THAT RELOADS WITH CSH/TT <1 IN LSG INCLUDING STAPLES WITH CSH OF 1 MM ON BODY AND FUNDUS ARE SAFE. THE RESULTS CHALLENGE THE CONCEPT THAT TIGHT STAPLING CAUSE¿S ISCHEMIA. SINCE TIGHT RELOADS ARE DESIGNED TO IMPROVE HEMOSTASIS, THEIR APPLICATION COULD HAVE CLINICAL BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482109 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention