BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILS 21MM CURVED

    MDR report key: 17839765 · Received September 28, 2023

    Report

    Report Number
    3005075853-2023-07011
    Event Type
    Death
    Date Received
    September 28, 2023
    Date of Event
    September 17, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003441
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/28/2023. 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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 JOURNAL ARTICLE: TITLE: PRELIMINARY EVALUATION OF TWO-ROW VERSUS THREE-ROW CIRCULAR STAPLERS FOR COLORECTAL ANASTOMOSIS AFTER RECTAL RESECTION: A SINGLE-CENTER RETROSPECTIVE ANALYSIS. AUTHOR: GIUSEPPE QUERO, CLAUDIO FIORILLO, ROBERTA MENGHI, FAUSTO ROSA, GIUSEPPE MASSIMIANI1, CARLO ALBERTO SCHENA, DAVIDE DE SIO, VITO LATERZA, CHIARA LUCINATO, VALERIO PAPA, VINCENZO TONDOLO , SERGIO ALFIERI. CITATION: INTERNATIONAL JOURNAL OF COLORECTAL DISEASE HTTPS:/ /DOI.ORG/10.1007/S00384-022-04283-8. THE AIM OF THIS STUDY IS TO EVALUATE POTENTIAL ADVANTAGES OF THREE-ROW CIRCULAR STAPLERS (THREE-CS) ON ANASTOMOTIC LEAKAGE (AL), STENOSIS (AS), AND HEMORRHAGE (AH) RATES AFTER RECTAL RESECTION AS COMPARED TO TWO-ROW CIRCULAR STAPLERS (TWO-CS). ALL RECTAL RESECTIONS FOR RECTAL CANCER BETWEEN 2016 AND 2021 WERE RETROSPECTIVELY INCLUDED. PATIENTS WERE CLASSIFIED ACCORDING TO THE CIRCULAR STAPLER EMPLOYED IN TWO-CS AND THREE-CS COHORTS. 375 PATIENTS UNDERWENT A RECTAL RESECTION WITH AN END-TO-END ANASTOMOSIS DURING THE STUDY PERIOD: 197 CONSTITUTED THE TWO-CS GROUP AND 178 THE THREE-CS COHORT. TWO-ROW CIRCULAR STAPLER (TWO- CS GROUP), CIRCULAR STAPLER¿ECP, ETHICON OR MEDTRONIC FROM OUR COMPETITOR USED IN ALL THE PROCEDURES PERFORMED. FOR PATIENTS UNDERWENT A COLORECTAL ANASTOMOSIS USING A THREE-ROW CIRCULAR STAPLER (THREE-CS GROUP), THEY USED A DEVICE FROM ONE OF OUR COMPETITORS, MEDTRONIC. REPORTED COMPLICATIONS ANASTOMOTIC LEAKAGE (AL) - (N-?). ANASTOMOTIC STENOSIS (AS)- (N?). ANASTOMOTIC HEMORRHAGE (AH) ¿ (N-?). CONCLUSION: THREE-ROW CSS SIGNIFICANTLY DECREASE THE RATE OF AL AFTER RECTAL RESECTION. FURTHER MULTICENTER CONTROLLED TRIALS ARE STILL NEEDED TO CONFIRM THE ADVANTAGES OF THREE-ROW CSS ON ANASTOMOTIC COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010589 ILS 21MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036003441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R