BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION

    MDR report key: 22952336 · Received September 3, 2025

    Report

    Report Number
    3004962788-2025-00103
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    October 27, 2021
    Report Date
    September 3, 2025
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K151376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: AAS00161-20, AAS00161-20 US SUPERD NAVIGATION SYSTEM (SERIAL#UNKNOWN) ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY VERSUS VIRTUAL BRONCHOSCOPY NAVIGATION FOR IMPROVING THE DIAGNOSIS OF PERIPHERAL LUNG LESIONS: ANALYSIS OF THE PREDICTORS OF SUCCESSFUL DIAGNOSIS / YOJIRO YUTAKA, TOSHIHIKO SATO, MASAHIDE ISOWA, YOSHITAKE MURATA, SATONA TANAKA, YOSHITO YAMADA, AKIHITO OHSUMI, DAISUKE NAKAJIMA, MASATSUGU HAMAJI, TOSHI MENJU, TOYOFUMI FENGSHI CHEN-YOSHIKAWA, HIROSHI DATE / SURGERY TODAY (2022) 52:923¿930 / HTTPS://DOI.ORG/10.1007/S00595-021-02398-Z / PUBLISHED ONLINE: 27 OCTOBER 2021 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 A RETROSPECTIVE LITERATURE SOURCE OF A STUDY PERFORMED BETWEEN FEBRUARY 2016 AND DECEMBER 2019 TO COMPARE THE RESULTS OF 100 PATIENTS WHO UNDERWENT THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY-TRANSBRONCHIAL LUNG BIOPSIES (TBLBS) WITH THOSE OF 50 VIR TUAL BRONCHOSCOPY NAVIGATION (VBN)-TBLBS AT A SINGLE INSTITUTION. COMPLICATIONS INCLUDED INCOMPLETE REGISTRATION IN TWO PATIENTS (2%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331608 SUPERDIMENSION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC AAS00161-20 10884521199989

    Patients

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