BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 23794961 · Received December 12, 2025

    Report

    Report Number
    2647580-2025-03702
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    September 16, 2025
    Report Date
    December 12, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A. AKMERCAN, K. D. BATUN, H. I. SEVINDI, T. AKMERCAN, T. K. UPRAK SINGLE-PORT LAPAROSCOPIC VERSUS OPEN HARTMANN¿S REVERSAL: A RETROSPECTIVE ANALYSIS ON SURGICAL AND POSTOPERATIVE OUTCOMES, TECHNIQUE S IN COLOPROCTOLOGY, ISSUE 1, 2025, HTTPS://DOI.ORG/10.1007/S10151-025-03229-W. 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 SOURCE OF STUDY PERFORMED BETWEEN 2019 AND 2022, A RETROSPECTIVE STUDY AIMED TO COMPARE THE SURGICAL AND POSITIVE OUTCOMES OF SINGLE-PORT LAPAROSCOPIC HARTMANN¿S REVERSAL (SPLHR) AND OPEN HARTMANN¿S REVERSAL (OHR). THE CIRCULAR STAPLER WAS USED TO PERFORM THE COLORECTAL ANASTOMOSES, AN END TO-END OR END-TO-SIDE TRANSANALLY AND A LEAK TEST WAS PERFORMED AFTER. A TOTAL OF 47 PATIENTS WERE INCLUDED IN THE STUDY WITH 23 WHO UNDERWENT SPLHR AND 24 WHO UNDERWENT OHR. POSTOPERATIVE COMPLICATIONS INCLUDED ANASTOMOTIC LEAK AND BLEEDING. HOSPITAL READMISSION WAS DONE. OTHER COMPLICATIONS THAT WERE NOT RELATED TO THE DEVICE INCLUDED INTRAOPERATIVE ORGAN INJURY, WOUND INFECTION, DELAYED BOWEL MOVEMENT AND OTHER MEDICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2770720 UNKNOWN EEA STAPLE, IMPLANTABLE GDW COVIDIEN UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization