BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SURGICAL INNOVATIONS BO PRODUCT

    MDR report key: 22738860 · Received August 7, 2025

    Report

    Report Number
    1717344-2025-01011
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    April 24, 2025
    Report Date
    August 7, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNK-SIGADAPT, UNKNOWN SIGNIA EGIA ADAPTER (SERIAL#: UNKNOWN); UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#: UNKNOWN) FEASIBILITY OF THE HINOTORI¿ SURGICAL ROBOT SYSTEM IN RIGHT COLECTOMY: A PROPENSITY SCORE MATCHING STUDY / YOSHIAKI FUJII, HIROYUKI ASAI, SHUHEI UEHARA, AKIRA KATO, KAORI WATANABE, TAKUYA SUZUKI, HAJIME USHIGOME, YUSHI YAMAKAWA, HIROKI TAKAHASHI, SHUJI TAKIGUCHI / SURGICAL ENDOSCOPY (2025) 39:4006¿4016 / HTTPS://DOI.ORG/10.1007/S00464-025-11771-9 / PUBLISHED ONLINE: 12 MAY 2025. 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 88 CASES OF ROBOTIC RIGHT HEMICOLECTOMY WAS COMPLETED BETWEEN 2020 AND 2024. BRANDED PRODUCTS WERE USED ONLY IN THE HINOTORI ROBOTIC PROCEDURES. SONICISION WAS USED FOR VESSEL TRANSECTION. ONE UNDESCRIBED COMPLICATION WAS REPORTED. NO INTERVENTIONS WERE DESCRIBED; HOWEVER, IT WAS MENTIONED THAT NO REOPERATIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218892 UNKNOWN SURGICAL INNOVATIONS BO PRODUCT Electrosurgical, cutting & coagulation & accessories GEI COVIDIEN UNKNOWN SURGICAL INNOVATIONS BO PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE NOTE ON H11.