BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREQ

    MDR report key: 23942628 · Received January 2, 2026

    Report

    Report Number
    3012037425-2026-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 5, 2025
    Report Date
    February 24, 2026
    Manufacturer
    VITREQ BV
    Product Code
    HMX
    UDI-DI
    88719214220910
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    VITREQ B.V. HAS INVESTIGATED THE COMPLAINT IN ACCORDANCE WITH THE ESTABLISHED INTERNAL PROCEDURE. THE VISUAL INSPECTION OF THE RETURNED PART REVEALED THAT THE DEVICE DOES CONTAIN A SILICONE TIP; HOWEVER, THE TIP SEEMS TO BE CUT OFF. REMAINS OF THE TIP ARE STILL VISIBLE. THE PRODUCTION RECORDS OF THE INVOLVED LOT WERE REVIEWED AND NO ANOMALIES WERE FOUND IN RELATION TO THE INVESTIGATED FAILURE. BASED ON THAT WE COULD EXCLUDE A MANUFACTURING DEFICIENCY RELATED TO THE PRODUCT IN QUESTION AND CONCLUDED THE FAILURE MODE IS INHERENT TO THE DESIGN OF SOFT-TIPPED DEVICES AND AN IFU WARNING IS IN PLACE "CAREFULLY INSERT THE INSTRUMENT INTO THE CANNULA, TOO MUCH FRICTION MAY CAUSE DELICATE PARTS TO SEPARATE. ALWAYS CHECK THE INSTRUMENT ON DAMAGE DURING AND AFTER SURGERY." AND THEREFORE, THIS EVENT IS CLASSIFIED AS USER HANDLING. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY. VITREQ WILL CONTINUE TO MONITOR ANY FEEDBACK FROM OUR CUSTOMERS AND TAKE APPROPRIATE ACTION IF UNFAVOURABLE TRENDS ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    ON DECEMBER 8, 2025, BVI VITREQ WAS INFORMED OF AN ISSUE CONCERNING OUR PRODUCT, BF25.D02. ACCORDING TO THE CUSTOMER, THE SILICONE TIP WAS FOUND TO BE MISSING PRIOR TO USE DURING THE PROCEDURE. AT THAT TIME, THE COMPLAINT WAS CONSIDERED NOT REPORTABLE, AND A PRODUCT RETURN WAS INITIATED. AFTER THE PRODUCT WAS RECEIVED AND EVALUATED, IT WAS CONCLUDED THAT, CONTRARY TO THE INITIAL ALLEGATION, THE BACKFLUSH WAS MOST LIKELY USED DURING SURGERY AND THAT THE TIP DETACHED AT SOME POINT DURING THE PROCEDURE. AS FAR AS BVI IS CURRENTLY AWARE, THERE WAS NO PATIENT IMPACT. THE MOST LIKELY SCENARIO IS THAT THE SURGEON IMMEDIATELY NOTICED THAT THE TIP HAD DETACHED AND REMOVED THE TIP REMNANTS FROM THE EYE AS PART OF THE ONGOING PROCEDURE. ALTHOUGH NONE OF THE INFORMATION RECEIVED TO DATE INDICATES THAT HARM OCCURRED, THE FAILURE MODE HAS THE POTENTIAL TO CAUSE SERIOUS INJURY IF IT RECURS. THEREFORE, THE EVENT IS CONSIDERED REPORTABLE TO THE COMPETENT AUTHORITIES AS A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6628 VITREQ 25G BRUSH BACKFLUSH INSTRUMENT HMX VITREQ BV BF25.D02 20246069 88719214220910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown