BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 21401605 · Received February 18, 2025

    Report

    Report Number
    1219930-2025-00851
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    November 3, 2024
    Report Date
    February 18, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E1, E3 PUSHING BOUNDARIES: SIMULTANEOUS MINIMAL-INVASIVE RESECTION OF COMPLEX COLORECTAL LIVER METASTASES AND ITS PRIMARY TUMOR / DR. (B)(6) / SURGICAL ENDOSCOPY (2025) 39:401¿408 / HTTPS://DOI.ORG/10.1007/S00464-024-11411-8 / PUBLISHED ONLINE: 20 NOVEMBER 2024. 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

    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 STUDY PERFORMED BETWEEN MAY 2015 AND DECEMBER 2021, A RETROSPECTIVE STUDY ANALYZES THE SIMULTANEOUS MINIMALLY INVASIVE RESECTION OF COLORECTAL LIVER METASTASES AND PRIMARY TUMOR. OUT OF 281 PATIENTS UNDERGOING RESECTION OF COLORECTAL LIVER METASTASES (CRLM), 33 (11.7%) PATIENTS HAD SIMULTANEOUS MINIMAL INVASIVE RESECTION OF THE COLORECTAL PRIMARY. PARENCHYMAL DISSECTION OF THE LIVER WAS PERFORMED WITH ENDO GIA OR A COMPETITOR PRODUCTS. POSTOPERATIVE COMPLICATION INCLUDED BILIARY LEAKAGE REQUIRING PERCUTANEOUS DRAINAGE OCCURRED IN TWO PATIENTS. OTHER COMPLICATIONS UNRELATED TO THE DEVICE INCLUDED PORT INFECTION, PARACOLIC FLUID COLLECTION, AND RECTAL STUMP INSUFFICIENCY. ONE NON-DEVICE RELATED PATIENT MORTALITY WAS ALSO MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523650 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other