BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 15581901 · Received October 11, 2022

    Report

    Report Number
    3005075853-2022-06825
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    January 1, 2015
    Report Date
    October 10, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT IS 2015, EVENT DAY AND MONTH UNKNOWN. CAPTURED AS (B)(6) 2015. BATCH #UNK. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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

    IT WAS REPORTED VIA THE RISK MANAGER, RECEIVED NOTICE OF CLAIM AND MEDICAL RECORDS FROM WHICH INDICATE PATIENT WITH HISTORY OF MORBID OBESITY UNDERWENT LAPAROSCOPIC BILIOPANCREATIC DIVERSION W/DUODENAL SWITCH, INTEROPERATIVE EGD AND APPENDECTOMY. OPERATIVE NOTE STATES THE SLEEVE GASTRECTOMY WAS PERFORMED FIRST WITH TWO FIRINGS OF THE GREEN LOAD STAPLER AND THEN SUCCESSIVE FIRINGS OF THE GOLD LOAD ¿ENDO-GIA 60 STAPLER.¿ THE STAPLE LINE WAS THEN OVERSEWN WITH 2-0 VICRYL TO THE PROXIMAL HALF OF THE STAPLE LINE. AN INTRAOPERATIVE EGD WAS PERFORMED, AND A SALINE BUBBLE TEST OF THE DUODENOILEOSTOMY FOUND NO EVIDENCE OF A LEAK. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO POST-SURGICAL FLOOR FOR RECOVERY. THE PATIENT WAS DISCHARGED 5 DAYS LATER. ONE MONTH LATER, THE PATIENT PRESENTED TO THE ER FOR SYNCOPE AND COLLAPSE, AND WAS FOUND TO HAVE A LEAK. OPERATIVE NOTE PROVIDED STATES ¿JUST DISTAL TO THE GE JUNCTION, A SMALL APPROXIMATELY 1 CM OPENING IN THE STAPLE LINE COULD BE IDENTIFIED.¿ TISSEEL FIBRIN GLUE WAS USED TO ADDRESS THE LEAK. POST OPERATIVELY PATIENT DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE PLACEMENT. ALMOST ONE MONTH POST OP, THE PATIENT WAS AGAIN FOUND TO HAVE A LEAK. OPERATIVE NOTE STATES ¿AT 40 CM FROM THE INCISORS AT THE PROXIMAL ASPECT OF THE GASTRIC STAPLE LINE, SHE AGAIN IS FOUND TO HAVE EVIDENCE OF A LEAK. AT THIS POINT, THERE ARE VISIBLE STAPLES WITHIN THE OPENING TO THE LEAK SITE.¿ BIOPSY FORCEPS WERE USED TO REMOVE THE STAPLES AND TISSEEL SLOWLY ADMINISTERED TO ADDRESS THE LEAK. CURRENT CONDITION OF PATIENT IS UNKNOWN AS NO FURTHER TREATMENT RECORDS ARE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305960 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization| R