BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTEYE CONSOLE

    MDR report key: 22046236 · Received May 19, 2025

    Report

    Report Number
    1045254-2025-01365
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 21, 2025
    Report Date
    December 8, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    QDF
    UDI-DI
    00763000849573
    PMA / PMN Number
    DEN170056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    B5: NEW INFORMATION RECEIVED. H6: INITIALLY SUBMITTED CODES FDR C21, FDC D16 ARE NO LONGER APPLICABLE. SECTION E: INITIAL REPORTER INFORMATION UPDATED. 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 DURING A CASE THE SURGEON WAS VISUALLY IDENTIFYING TISSUE TO BE PARATHYROID TISSUE, BUT THE PTEYE SYSTEM WAS NOT DETECTING IT AS SUCH. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THYROID TISSUE WAS USED FOR THE BASELINE AND 5 READINGS TAKEN FROM DIFFERENT LOCATIONS. THE PROBE FUNCTIONED NORMALLY. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF PTEYE CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138936 PTEYE CONSOLE PARATHYROID AUTOFLUORESCENCE DETECTION DEVICE QDF MEDTRONIC XOMED INC. PTEYE 00763000849573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown