BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEA

    MDR report key: 24799084 · Received April 7, 2026

    Report

    Report Number
    2647580-2026-00970
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 16, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    UDI-DI
    10884521593138
    PMA / PMN Number
    K172361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 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.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANT PRODUCTS: 020242 020242 DISP PURSE STRING 65 X3 - (LOT# UNKNOWN). 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 REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOW ANTERIOR RESECTION, DURING ANASTOMOSIS, THE ANVIL AND RELOAD OF THE CIRCULAR STAPLER WERE FULLY CONNECTED BUT THERE WERE HOLES IN THE STAPLE LINE. THE SECOND DEVICE WAS FIRED AND THERE WAS A STAPLE LINE BLEEDING. THE SURGEON RESECTED AND RESTAPLED THE ANASTOMOSIS TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859071 EEA STAPLER, SURGICAL GAG COVIDIEN TRIEEAXL28XT 10884521593138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11