BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 14455144 · Received May 20, 2022

    Report

    Report Number
    3005075853-2022-03287
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    March 23, 2020
    Report Date
    May 19, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNKNOWN. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: SURGICAL MANAGEMENT OF SIGMOID VOLVULUS: A MULTICENTER OBSERVATIONAL STUDY. AUTHORS: KEUNCHUL LEE, HEUNG-KWON OH, JUNG RAE CHO, MINHYUN KIM, DUCK-WOO KIM, SUNG-BUM KANG, HYUNG-JIN KIM, HYOUNG-CHUL PARK, RUMI SHIN, SEUNG CHUL HEO, SEUNG-BUM RYOO, KYU JOO PARK. CITATION CITE: ANN COLOPROCTOL 2020;36(6):403-408. HTTPS://DOI.ORG/10.3393/AC.2020.03.23. THIS STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES BETWEEN EMERGENCY AND ELECTIVE SURGERY PATIENTS TREATED FOR SIGMOID VOLVULUS. FIVE TERTIARY CENTERS PARTICIPATED IN THIS RETROSPECTIVE STUDY WITH DATA COLLECTED FROM OCTOBER 2003 THROUGH SEPTEMBER 2018, INCLUDING DEMOGRAPHIC INFORMATION, PREOPERATIVE CLINICAL DATA, AND INFORMATION ON LAPAROSCOPIC/OPEN AND ELECTIVE/EMERGENCY PROCEDURES. OUTCOME MEASUREMENTS INCLUDED OPERATION TIME, POSTOPERATIVE HOSPITALIZATION, AND POSTOPERATIVE MORBIDITY. AMONG 74 PATIENTS, SIGMOIDECTOMY WAS THE MOST COMMON PROCEDURE (N=46), FOLLOWED BY HARTMANN¿S PROCEDURE (N=23), AND SUBTOTAL COLECTOMY (N=5). EMERGENCY SURGERY WAS PERFORMED IN 35 CASES (47.3%). OF THE 35 EMERGENCY PATIENTS, 34 CASES (97.1%) UNDERWENT OPEN SURGERY, AND A STOMA WAS ESTABLISHED FOR 26 PATIENTS (74.3%). ELECTIVE SURGERY WAS PERFORMED IN 39 CASES (52.7%), INCLUDING 21 OPEN PROCEDURES (53.8%), AND 18 LAPAROSCOPIC SURGERIES (46.2%). MEDIAN LAPAROSCOPIC OPERATION TIME WAS 180 MINUTES, WHILE MEDIAN OPEN SURGERY TIME WAS 130 MINUTES (P<0.001). MEDIAN POSTOPERATIVE HOSPITALIZATION WAS 11 DAYS FOR LAPAROSCOPY AND 12 DAYS FOR OPEN SURGERY.NEXT, TRANSECTION OF THE UPPER RECTUM WAS PERFORMED USING AN ENDOSCOPIC LINEAR STAPLER (ECHELON 60, ETHICON INC., CINCINNATI, OH, USA). WE THEN EXTENDED THE UMBILICAL OR LUQ TROCAR SITE FOR DELIVERING THE SIGMOID COLON. THE ANVIL OF A CIRCULAR STAPLER WAS INSERTED INTO THE END OF THE DELIVERED BOWEL, AND INTRACORPOREAL END-TO-END ANASTOMOSIS WAS PERFORMED THROUGH THE ANUS (ECS 29, ETHICON INC.) REPORTED COMPLICATIONS INCLUDED ILEUS(N=12) , WOUND COMPLICATION (N=8), ANASTOMOSIS LEAKAGE (N=4), SEPSIS (N=2). IN CONCLUSION RELATIVE TO ELECTIVE SURGERY, EMERGENCY SURGERY HAD A HIGHER RATE OF POSTOPERATIVE COMPLICATIONS, OPEN SURGERY, AND STOMA FORMATION. AS SUCH, ELECTIVE LAPAROSCOPIC SURGERY AFTER SUCCESSFUL SIGMOIDOSCOPIC DECOMPRESSION MAY BE THE OPTIMAL CLINICAL OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470412 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention