BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 18387558 · Received December 22, 2023

    Report

    Report Number
    3005075853-2023-09801
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    May 9, 2023
    Report Date
    December 22, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/22/2023. D4: BATCH # UNK. 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. 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? 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

    TITLE: TO CUT OR NOT TO CUT? A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL ON SHORT-TERM OUTCOMES OF THE UNCUT ROUX-EN-Y RECONSTRUCTION FOR GASTRIC CANCER. AUTHORS: HAO XU· LI YANG· DIAN-CAI ZHANG· ZHENG LI· QING-YA LI· LIN-JUN WANG· FENG-YUAN LI· WEI-ZHI WANG· YI-WEN XIA· ZE-KUAN XU. CITATION: SURGICAL ENDOSCOPY (2023) 37:6172¿6184. HTTPS://DOI.ORG/10.1007/S00464-023-10067-0. THE OBJECTIVE OF THIS STUDY IS TO TO COMPARE THE SURGICAL SAFETY, NUTRITIONAL STATUS, AND POSTOPERATIVE QUALITY OF LIFE (QOL) BETWEEN UNCUT AND CLASSIC ROUX-EN-Y (R-Y) RECONSTRUCTION PATIENTS. BETWEEN APRIL 2016 AND OCTOBER 2019, A TOTAL OF 170 PATIENTS WERE REGISTERED PROSPECTIVELY; 85 PATIENTS WERE RANDOMLY ASSIGNED TO THE R-Y GROUP AND 85 PATIENTS TO THE UNCUT R-Y GROUP. IN TERMS OF POSTOPERATIVE COMPLICATIONS, THE MORBIDITY RATES IN THE R-Y GROUP WERE (4/72) AND (7/76) IN THE UNCUT R-Y GROUP). HOWEVER, THE COMPLICATIONS IN THE LATTER APPEARED MORE SERIOUS THAN THOSE IN THE R-Y GROUP, AND 2 GRADE III CASES WERE IDENTIFIED IN THE UNCUT R-Y GROUP. A STAPLER WITHOUT A BLADE (ETHICON ENDO-SURGERY AKT45) WAS USED TO BLOCK THE AFFERENT JEJUNUM. THE SMALL BOWEL WAS RETURNED TO THE ABDOMINAL CAVITY AND THE PNEUMOPERITONEUM WAS RECONSTRUCTED AFTER CLOSING THE ABDOMINAL INCISION. THE JEJUNUM, 5 CM DISTALLY TO THE OCCLUSIVE LINE, WAS ANASTOMOSED TO THE SIDE OF THE RESIDUAL STOMACH USING A 60-MM LINEAR STAPLER (ETHICON ENDO-SURGERY ECHELON 60). IN THE R-Y GROUP, A NORMAL LINEAR STAPLER WITH A BLADE (ETHICON ENDO-SURGERY ECHELON 60) WAS USED. REPORTED COMPLICATIONS INCLUDED BLEEDING (N=?) AND POSTOPERATIVE COMPLICATIONS (N=11). IN CONCLUSION, WE FOUND NO SIGNIFICANT BENEFIT OF UNCUT OVER CLASSIC R-Y RECONSTRUCTION WHICH CHALLENGES THE SUPERIORITY OF THE UNCUT R-Y RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324289 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention