BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 21792663 · Received April 7, 2025

    Report

    Report Number
    1219930-2025-01625
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 7, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BERNARDO DALLA VALLE, ALESSIA FASSARI, ANDREA RUZZENENTE, BENEDETTO IELPO, RICCARDO MEMEO, VALENTINA FERRARO, TULLIO PIARDI, MARCELLO GIUSEPPE SPAMPINATO, ANNARITA LIBIA, PATRICK PESSAUX, FABIO GIANNONE, EMMANUEL MELLOUL, TZEDAKIS STYLIANOS, DAVID FUKS, VITO DE BLASI. SAFETY AND FEASIBILITY OF ROBOTIC APPROACH TO CHOLEDOCHAL CYSTS IN ADULTS: A MULTICENTER EUROPEAN EXPERIENCE, JOURNAL OF ROBOTIC SURGERY, ISSUE # 1, 2025, 10.1007/S11701-025-02258-9 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 ASSESS THE SAFETY AND FEASIBILITY OF ROBOTIC APPROACH FOR CHOLEDOCHAL CYST EXCISION. IN 11 PATIENTS, THE HEPATOJEJUNOSTOMY WAS PERFORMED USING TWO 4-0 SUTURES. THERE WERE 22 ADULT PATIENTS AND COMPLICATIONS INCLUDED BILIARY LEAK AND ABSCESS. ONE PATIENT REQUIRED REOPERATION TO RESOLVE THE ISSUE. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED ABDOMINAL BLEEDING, POSTOPERATIVE AND PANCREATIC FISTULA. SAFETY AND FEASIBILITY OF ROBOTIC APPROACH TO CHOLEDOCHAL CYSTS IN ADULTS: A MULTICENTER EUROPEAN EXPERIENCE. AZIENDA OSPEDALIERA UN IVERSITARIA, PIAZZALE ARISTIDE STEFANIE, 1 / 37126 VERONA ITALY, EMAIL ADDRESS: [email protected]. HTTPS://DOI.ORG/10.1007/S11701-025-02258-9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645658 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention