BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE

    MDR report key: 23152907 · Received September 26, 2025

    Report

    Report Number
    3004962788-2025-00111
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 30, 2025
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    PMA / PMN Number
    K151376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: SD300LG, SD300LG EDGE LOCATABLE GUIDE X1 (LOT#:529799) 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

    ADDITIONAL INFORMATION: G3, H3, H6. H3. EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE EXTENDED WORKING CHANNEL (EWC) WAS KINKED 400MM FROM THE END OF THE HANDLE. THE INNER DIAMETER OF THE EWC WAS CHECKED WITH A BALL MANDREL, BUT IT WAS UNABLE TO SMOOTHLY PASS THROUGH THE KINK. IT WAS REPORTED THAT THE EXTENDED WORKING CHANNEL (EWC) AND LOCATABLE GUIDE DID NOT FIT OR HAD IMPROPER FIT. THE REPORTED ISSUES WERE CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. IT WAS ALSO REPORTED THAT THE REGISTRATION WAS ALWAYS UNSUCCESSFUL DUE TO ELECTROMAGNETIC SIGNAL ISSUES. THIS WAS ATTRIBUTED TO ANOTHER DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: DO NOT ATTEMPT TO ROTATE OR MOVE THE EXTENDED WORKING CHANNEL WHEN IT IS SECURED IN THE BRONCHOSCOPE ADAPTER AS DAMAGE TO THE EXTENDED WORKING CHANNEL MAY OCCUR. 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

    IT WAS REPORTED THAT DURING THE PROCEDURE, REGISTRATION WAS ALWAYS UNSUCCESSFUL DUE TO ELECTROMAGNETIC SIGNAL ISSUES. THE DOTTED PATH OF THE CATHETER SEEN ON THE BRONCHIAL COUNT INTERFACE WAS INCONSISTENT WITH THE ACTUAL PATH. IT WAS NOTED THAT THE EXTENDED WORKING CHANNEL (EWC) AND LOCATABLE GUIDE DID NOT FIT OR HAD IMPROPER FIT. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA. THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE WAS COMPLETED BY OTHER MEANS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279015 EDGE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC SD180EWCTE-FT 530153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11