BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 22185899 · Received June 11, 2025

    Report

    Report Number
    1219930-2025-02516
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 11, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EARLY EXPERIENCE WITH ENDOROBOTIC SUBMUCOSAL DISSECTION (ERSD) PATHOLOGIC AND SHORT-TERM OUTCOMES IN THE FIRST 28 PATIENTS / (B)(6) / (ANN SURG 2025;281:884¿889) / HTTPS://DOI.ORG/10.1097/SLA.0000000000006346. 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 INCLUDING 28 CASES OF ENDOROBOTIC SUBMUCOSAL DISSECTION USING THE DA VINCI SINGLE PORT SYSTEM FOR COLORECTAL MUCOSAL NEOPLASMS WAS COMPLETED BETWEEN 2020 AND 2023. THE PROCEDURE WAS PERFORMED ROBOTICALLY UTILIZING A BARBED SUTURE TO CLOSE THE MUCOSAL DEFECT. COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING WITHOUT AN ACTIVE SOURCE, WHICH WAS OBSERVED DURING AN ENDOSCOPIC PROCEDURE AND REQUIRED A BLOOD TRANSFUSION. IT WAS ALSO NOTED THAT ONE OF THE INTERVENTIONS ALSO INCLUDED PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86581 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R