BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTEYE-1 FIBER OPTIC PROBE

    MDR report key: 22048567 · Received May 19, 2025

    Report

    Report Number
    1045254-2025-01366
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 17, 2025
    Report Date
    November 20, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    QDF
    UDI-DI
    00763000497057
    PMA / PMN Number
    DEN170056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    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 THE PTEYE PROBE WOULD NOT RESPOND WHEN ON TISSUE AND FOOT PEDAL WAS ENGAGED. OPENED A SECOND PROBE AND IT WORKED FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PTEYE PROBE WOULD NOT RESPOND WHEN ON TISSUE AND FOOT PEDAL WAS ENGAGED. OPENED A SECOND PROBE AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050745 PTEYE-1 FIBER OPTIC PROBE PARATHYROID AUTOFLUORESCENCE DETECTION DEVICE QDF MEDTRONIC XOMED INC. PTEYE-1 0230298796 00763000497057

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female