BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 20397909 · Received October 8, 2024

    Report

    Report Number
    2647580-2024-04341
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    May 16, 2024
    Report Date
    October 8, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    USEFULNESS OF A POWERED CIRCULAR STAPLER COMPARED WITH A MANUAL CIRCULAR STAPLER IN PATIENTS UNDERGOING COLORECTAL CANCER SURGERY: A RETROSPECTIVE COHORT STUDY AND SYSTEMATIC REVIEW. RIE MIZUMOTO, NORIKATSU MIYOSHI, RIE HAYASHI, SHINYA KATO, SOICHIRO MINAMI, MITSUNOBU TAKEDA, YUKI SEKIDO, TSUYOSHI HATA, ATSUSHI HAMABE, TAKAYUKI OGINO, MITSUYOSHI TEI, YOSHINORI KAGAWA, MAMORU UEMURA, YUICHIRO DOKI AND HIDETOSHI EGUCHI. ONCOLOGY LETTERS 28: 507, 2024 / ACCEPTED MAY 16, 2024 / DOI: 10.3892/OL.2024.14640 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY AIMED TO CLARIFY THE USEFULNESS OF THE AUTOMATIC ANASTOMOSIS DEVICE IN PATIENTS WHO UNDERWENT RADICAL RESECTION AND ANASTOMOSIS FOR SIGMOID COLON OR RECTAL CANCER BETWEEN 2018 AND 2022. BOWEL DISSECTION WAS PERFORMED USING A STAPLER. MANUAL ANASTOMOSIS WAS PERFORMED USING THE EEA CIRCULAR STAPLER OR A COMPETITOR CIRCULAR STAPLER, AND AUTOMATIC ANASTOMOSIS WAS PERFORMED USING A POWERED STAPLER. AN AIR LEAK TEST WAS INTRAOPERATIVELY PERFORMED AFTER ANASTOMOSIS IN ALL CASES AND NO AIR LEAK WAS CONFIRMED IN ALL CASES. EIGHT PATIENTS IN THE MANUAL ANASTOMOSIS GROUP EXPERIENCED ANASTOMOTIC COMPLICATIONS WHICH INCLUDED ANASTOMOTIC LEAKAGE AND BLEEDING. INTERVENTIONS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635649 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other