BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 6807458 · Received August 21, 2017

    Report

    Report Number
    3005075853-2017-04195
    Event Type
    Injury
    Date Received
    August 21, 2017
    Report Date
    July 27, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 8/21/2017. BATCH # UNK. 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. DO THE SURGEONS BELIEVE THE ADVERSE EVENT WAS RELATED TO THE ECHELON STAPLER? WHAT COLOR CATEGORY, BLACK OR GREEN, WERE THE ADVERSE EVENT OF BLEEDING? EVENT DESCRIPTION CONTINUED: THE 3 REMAINING PATIENTS REQUIRED NO ADDITIONAL INTERVENTION. THREE PATIENTS REQUIRED READMISSION FOR DEHYDRATION WHICH RESOLVED IN 1-2 DAYS OF REHYDRATION WITH INTRAVENOUS FLUIDS. ONE PATIENT PRESENTED WITH NEAR-COMPLETE GASTRIC OBSTRUCTION SHORTLY FOLLOWING OPERATION. UPPER GI SERIES FLUOROSCOPY DEMONSTRATED A KINK AT THE UPPER ASPECT OF THE SLEEVE. THE PATIENT WENT THROUGH UNEVENTFUL LAPAROSCOPIC CONVERSION OPERATION TO ROUX-EN-Y GASTRIC BYPASS ON THE 5TH WEEK POST LSG. ONE PATIENT WAS ADMITTED FOR WOUND INFECTION THAT REQUIRED INCISION AND DRAINAGE AT THE SITE WHERE THE GASTRIC SPECIMEN WAS EXTRACTED DURING LSG.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE: 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: OBESITY SURGERY 2017;27:837-843; DOI 10.1007/S11695-016-2516-2 THE CURRENT STUDY¿S OBJECTIVES 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). THE STUDY INCLUDED A PROSPECTIVELY COLLECTED DATA ON 202 CONSECUTIVE PATIENTS WHO UNDERWENT NON-REVISIONAL (PRIMARY) LSG FOR MORBID OBESITY BETWEEN MARCH 2015 AND MARCH 2016 BY A SINGLE SURGEON. ECHELON FLEX ENDOPATH LINEAR STAPLER CARTRIDGES OF 60MM LENGTH WERE USED. ALL LAPAROSCOPIC TROCAR ENTRY SITES WERE INSPECTED FOR BLEEDING AND WERE SEALED AS NEEDED USING ENDO CLOSE WITH 2-0 VICRYL SUTURES. IN TOTAL, THERE WERE 34 (3.1%) STAPLE-RELATED MECHANICAL FAILURES. THESE WERE GENERALLY SPLITTING OF THE SERO-MASCULAR LAYER OR DEVELOPING OF STAPLE LINE HEMATOMA. IN RELATIVE PROPORTION, 23 (68%) OF THE MECHANICAL FAILURES OCCURRED IN THE FIRST PRE-PYLORIC APPLICATION WITH THE BLACK CARTRIDGE (CSH = 2.3 MM) WHERE NO THICKER STAPLERS ARE CURRENTLY AVAILABLE, 4 WERE WITH GREEN CARTRIDGES (CSH = 2.0 MM) AT THE ANTRUM, AND 4 WITH BLUE (CSH = 1.5 MM) AND 3 WITH WHITE (CSH = 1.0 MM) CARTRIDGES ON BODY SECTIONS. IN ALL OF THESE CONDITIONS, OVERSUTURING THE STAPLE-LINE WITH ABSORBABLE SUTURE RESOLVED THE PROBLEM. FIVE PATIENTS RECEIVED IN TOTAL 8 UNITS OF RED BLOOD CELLS AND 8 UNITS OF PLASMA FOR EVIDENCE OF INTRAPERITONEAL BLEEDING. OF THESE, 1 WAS RE-EXPLORED IN THE OPERATION ROOM TO CONTROL THE BLEEDING FROM THE STAPLE LINE AND 1 FOR DRAINAGE OF THE SPLENIC HILUM HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588049 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention