BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SION SURGICAL INSTRUMENT

    MDR report key: 23785631 · Received December 11, 2025

    Report

    Report Number
    3010363671-2025-00016
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 11, 2025
    Manufacturer
    SIGHT SCIENCES INC
    Product Code
    HMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PHYSICIAN WHO USED A SION DEVICE REPORTED THAT DURING USE OF THE DEVICE, IT APPEARED THAT THE TIP WAS BROKEN. THE PHYSICIAN WAS, HOWEVER, ABLE TO COMPLETE THE PROCEDURE WITH THE DEFECTIVE DEVICE. ALTHOUGH THERE WAS NO FOREIGN BODY LEFT BEHIND IN THIS INSTANCE, THERE IS A POTENTIAL RISK OF LEAVING A FOREIGN BODY IF THIS MALFUNCTION WERE TO RECUR THAT WILL NECESSITATE AN INTERVENTION TO REMOVE THE BROKEN PIECE (FOREIGN BODY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2761489 SION SURGICAL INSTRUMENT SION SURGICAL INSTRUMENT HMZ SIGHT SCIENCES INC F25F15-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention