BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM EXACT CODE UNKNOWN

    MDR report key: 21594730 · Received March 13, 2025

    Report

    Report Number
    3005075853-2025-01951
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    December 10, 2023
    Report Date
    March 13, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/13/2025. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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: OLDER VERSUS YOUNGER PATIENTS IN ROBOT-ASSISTED RADICAL CYSTECTOMY WITH INTRACORPOREAL ILEAL CONDUIT COMPARING SAFETY AND CLINICAL OUTCOMES. AUTHORS: DUTSADEE SOWANTHIP, KENJI ZENNAMI, TANAN BEJRANANDA, TAKUHISA NUKAYA, MASASHI TAKENAKA, MANABU ICHINO, KIYOSHI TAKAHARA, HITOMI SASAKI, MAMORU KUSAKA, MAKO TO SUMITOMO AND R YOICHI SHIROKI. CITATIONS: INTERNATIONAL JOURNAL OF UROLOGY (2024) 31, 370-378. DOI: 10.1111/IJU.15377. THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF ROBOT-ASSISTED RADICAL CYSTECTOMY USING AN INTRACORPOREAL ILEAL CONDUIT IN OLDER COMPARED TO YOUNGER PATIENTS. WE RETROSPECTIVELY ANALYZED 122 PATIENTS WHO UNDERWENT ROBOT-ASSISTED RADICAL CYSTECTOMY WITH AN INTRACORPOREAL ILEAL CONDUIT AT FUJITA HEALTH UNIVERSITY HOSPITAL AND FUJITA HEALTH UNIVERSITY OKAZAKI MEDICAL CENTER BETWEEN 2012 AND 2022. PATIENTS WERE CATEGORIZED INTO TWO GROUPS: OLDER (AGE C:'. 75 YEARS; N = 53) AND YOUNGER (AGE < 75 YEARS; N = 69). THE INTRACORPOREAL ILEAL CONDUIT WAS CONSTRUCTED USING A 60-MM LAPAROSCOPIC INTESTINAL STAPLER (ECHELON FLEX; ETHICON, CINCINNATI, OH, USA), WITH 15 CM OF THE TERMINAL ILEUM TAKEN 15 CM FROM THE ILEOCECAL VALVE AND STAPLED SIDE-TO-SIDE INTESTINAL ANASTOMOSIS AND RETROPERITONEAL TRANSFER OF THE LEFT URETER TO THE RIGHT SIDE. THE REPORTED COMPLICATIONS INCLUDED BOWEL ILEUS (N=21), GI BLEEDING (N=1), PERITONITIS (N=1), WOUND (N=8), URETERAL OBSTRUCTION (N=1), URINE LEAKAGE (N=2), STOMAL COMPLICATION (N=2), RENAL FAILURE (N=1), BLEEDING (N=1), AND SURGICAL COMPLICATION (N=1). IN CONCLUSION, ROBOT-ASSISTED RADICAL CYSTECTOMY WITH AN INTRACORPOREAL ILEAL CONDUIT IS A SAFE AND EFFECTIVE TREATMENT OPTION FOR OLDER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521904 PWRD ECH FLEX 60MM EXACT CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention