BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREQ

    MDR report key: 23411510 · Received October 29, 2025

    Report

    Report Number
    3012037425-2025-00001
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 27, 2025
    Report Date
    December 23, 2025
    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. IN ADDITION TO THE INFORMATION PROVIDED IN THIS SECTION WITH THE INITIAL EMDR, 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

    RETURNED DEVICE INVESTIGATION SHOWED TRACES OF USE AS SOME RESIDUAL LIQUID WAS OBSERVED. TIP WAS INDEED FOUND TO BE CUT OFF, CLEAR CUTTING MARKS ARE VISIBLE AND NO GLUE BOND ISSUES WERE IDENTIFIED AS THE SILICONE TIP REMAINS WERE FOUND TO BE ATTACHED TO THE CAPILLARY STILL. IT IS THUS CONFIRMED THAT THE TIP MUST HAVE COME OFF DURING TROCAR HANDLING. FLUSHING THE DEVICE WITH WATER SHOWED NORMAL FUNCTIONALITY AND NO LEAKS WERE OBSERVED AND THEREBY RULING OUT A MANUFACTURING ERROR. SUCH A SCENARIO IS COVERED IN THE DEVICE'S RISK MANAGEMENT FILES. DAMAGE OR DEFORMATION TO A SILICONE-TIPPED INSTRUMENT IS OFTENTIMES CAUSED BY INSTRUMENT HANDLING. WHEN THE DEVICE IS INSERTED THROUGH A VALVED TROCAR, THE FRAGILE SILICONE TIP MAY GET DAMAGED AND THIS IS INHERENT TO THE DESIGN CHARACTERISTICS OF THESE INSTRUMENTS. BVI VITREQ HAD INCLUDED A WARNING IN THE INSTRUCTIONS FOR USE TO INFORM USERS ABOUT THIS POTENTIAL FAILURE WHICH IS STATING "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." THE COMPLAINT HAS BEEN FORMALLY ACKNOWLEDGED AND RECORDED IN BVI'S COMPLAINT MANAGEMENT SYSTEM. BVI WILL CONTINUE TO MONITOR CUSTOMER FEEDBACK AND WILL TAKE APPROPRIATE ACTION SHOULD ANY UNFAVORABLE TREND BE OBSERVED.

    Description of Event or Problem · 0

    ON 01OCT2025, WE WERE NOTIFIED THAT THE "TIP CAME OFF DURING USE IN SURGERY" FOR A BF25.D02 BACKFLUSH DEVICE. HOSPITAL WAS CONTACTED TO REQUEST FOLLOW-UP INFORMATION FOR THE DEVICE WHERE THE TIP CAME OFF. AS FAR AS BVI IS CURRENTLY AWARE THERE IS NO PATIENT IMPACT, THE MOST LIKELY SCENARIO IS THAT THE SURGEON IMMEDIATELY NOTICED THAT THE TIP CAME OFF AND HAD REMOVED THE TIP REMAINS FROM THE EYE AS PART OF THE ONGOING PROCEDURE. ALTHOUGH NONE OF THE INFORMATION RECEIVED TO DATE POINT 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
    420386 VITREQ 25G BRUSH BACKFLUSH INSTRUMENT HMX VITREQ BV BF25.D02 20245410 88719214220910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown