BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREQ

    MDR report key: 23498475 · Received November 7, 2025

    Report

    Report Number
    3012037425-2025-00004
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 6, 2025
    Report Date
    December 9, 2025
    Manufacturer
    VITREQ B.V.
    Product Code
    HMX
    UDI-DI
    88719214220910
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    VITREQ B.V. HAS INVESTIGATED THE COMPLAINT IN ACCORDANCE WITH THE ESTABLISHED INTERNAL PROCEDURE. BASED ON THE ADDITIONAL INFORMATION GATHERED, THE DEVICE USED DURING THIS INCIDENT HAS BEEN DISCARDED AT THE CUSTOMER. NEVERTHELESS, UNUSED SAMPLES FROM THE SAME LOT WERE RETURNED AND INVESTIGATED. THE VISUAL INSPECTION PERFORMED SHOWED THAT ALL SILICONE TIP INCISIONS WERE NORMAL, NO DEVIATIONS WERE FOUND. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2025, BVI VITREQ WAS INFORMED ABOUT AN ISSUE CONCERNING OUR PRODUCT, BF25.D02. AS STATED BY THE CUSTOMER, AND VOLUNTARILY REPORTED TO THE ANSM, DURING INSERTION INTO THE VITRECTOMY TROCAR, THE SILICONE TIP DETACHED INSIDE THE EYE. OF THE THREE UNITS USED DURING TWO SEPARATE PROCEDURES (SAME BATCH NUMBER), TWO EXHIBITED THE SAME ISSUE. THE INCIDENT RESULTED IN A PROLONGATION OF THE OPERATING TIME. ADDITIONALLY, THE CUSTOMER EXPRESSED CONCERN ABOUT A POTENTIAL RISK OF LEAVING A PIECE OF TRANSPARENT SILICONE INSIDE THE EYE IF IT GOES UNNOTICED BY THE SURGEON. THE RISK RELATED TO DETACHMENT OF A SILICONE TIP FOR A BACKFLUSH DEVICE IS COVERED IN OUR RISK MANAGEMENT FILES. THE OTHER PROCEDURE IS REPORTED UNDER A SEPARATE EMDR REPORT #3012037425-2025-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180937 VITREQ 25G BRUSH BACKFLUSH INSTRUMENT HMX VITREQ B.V. BF25.D02 20259055R 88719214220910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown