BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GST RELOAD

    MDR report key: 22373973 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04990
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    March 16, 2021
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. 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 BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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: POTENTIAL URINARY FUNCTION BENEFITS OF INITIAL ROBOTIC SURGERY FOR RECTAL CANCER IN THE INTRODUCTORY PHASE. AUTHORS: HIROSHI OSHIO1,2 · YUKIKO OSHIMA2 · GEN YUNOME2 · MITSUYASU YANO1 · SHINJI OKAZAKI1 · YUYA ASHITOMI1 · HIROAKI MUSHA1 · YUKINORI KAMIO1 · FUYUHIKO MOTOI1. CITATION: JOURNAL OF ROBOTIC SURGERY (2022) 16:159¿168. HTTPS://DOI.ORG/10.1007/S11701-021-01216-5. THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE ADVANTAGES AND DISADVANTAGES OF INITIAL ROBOTIC SURGERY FOR RECTAL CANCER IN THE INTRODUCTION PHASE. BETWEEN 2015 AND 2018, A TOTAL OF 131 PATIENTS UNDERWENT SURGERY FOR RECTAL CANCER. CONVENTIONAL LAPAROSCOPIC SURGERY WAS PERFORMED IN 95 PATIENTS (60 WERE MALE; MEAN AGE OF 67.1 YEARS; MEAN BMI OF 23.8 KG/M2), AND ROBOTIC SURGERY WAS PERFORMED IN 36 PATIENTS (23 WERE MALE; MEAN AGE OF 62.1 YEARS; MEAN BMI OF 22.5 KG/M2). IN CASES OF ANTERIOR RESECTION (AR), THE DISTAL RECTUM WAS DIVIDED USING LINEAR STAPLERS [ECHELON FLEX¿ GST SYSTEM WITH A 60-MM GOLD OR BLACK CARTRIDGE (ETHICON ENDO-SURGERY, LLC., CINCINNATI, OH, USA) OR COMPETITOR DEVICE]. THE SPECIMEN WAS EXTRACTED THROUGH A 3¿6-CM INCISION IN THE UMBILICAL PORT. END-TO-END ANASTOMOSIS WAS PERFORMED USING THE STANDARD DOUBLE-STAPLING TECHNIQUE (DST) USING THE PROXIMATE¿ INTRALUMINAL STAPLER (CDH25A; ETHICON ENDO-SURGERY, LLC.) OR COMPETITOR DEVICE. FOR INTER-SPHINCTERIC RESECTION (ISR), WE PERFORMED TRANSANAL INTER-SPHINCTERIC DISSECTION AND COLO-ANAL HAND SEWN ANASTOMOSIS. FOR ABDOMINOPERINEAL RESECTION (APR), WE PERFORMED PERINEAL DISSECTION OF THE PELVIC DIAPHRAGM AND SIGMOID COLOSTOMY CONSTRUCTION. REPORTED COMPLICATIONS INCLUDE SURGICAL SITE INFECTION (N=?), ANASTOMOTIC LEAK (N=?), ILEUS (N=?), AND OTHERS (N=?). IN CONCLUSION, ROBOTIC SURGERY WAS PERFORMED SAFELY AND MAY IMPROVE FUNCTIONAL DISORDER IN THE INTRODUCTORY PHASE. THIS RESULT MAY DEPEND ON THE SURGEON PERFORMING ROBOTIC SURGERY AND ON STRICTLY CONFINED CRITERIA IN JAPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215138 UNKNOWN GST RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention