BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MICROFORCEPS: ILM.(23 GAUGE / 0.6 MM)

    MDR report key: 24113466 · Received January 20, 2026

    Report

    Report Number
    1222074-2026-00003
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 5, 2026
    Manufacturer
    D.O.R.C. DUTCH OPTHALMIC RESEARCH CENTER INT.
    Product Code
    HNR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IN REGARD TO THIS INCIDENT TWO 23-GAUGE DISPOSABLE ILM MICRO-FORCEPS WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION REVEALED DAMAGED TIPS, WHICH PREVENTED FUNCTIONAL TESTING. NO FURTHER INVESTIGATION WAS POSSIBLE DUE TO THE CONDITION OF THE TIPS. WHILE THE COMPROMISED MOVEMENT IS (PARTIALLY) INHERENT TO THE DESIGN OF THE ILM FORCEPS, CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO REDUCE THE OCCURRENCE OF SUCH FAILURES. BASED ON THE LOT NUMBER PROVIDED IN THE COMPLAINT FORM, IT WAS DETERMINED THAT THE PRODUCT INVOLVED IN THIS COMPLAINT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THESE CORRECTIVE ACTIONS. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. DESCRIPTION OF REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FSCA: DTP 2023-410 AND DTP 2025-401: ADOPT WAY OF ROUNDING EDGES AND ENDS OF ASSEMBLED PARTS AND CHANGE OF SCREW. SIMILAR SERIOUS INCIDENTS AND ASSOCIATED NUMBER OF DEVICES WERE DETERMINED BY TAKING THE NUMBER OF SERIOUS INCIDENTS RELATED TO THE IMDRF A CODE A0509 CORRESPONDING TO THE IN HOUSE CODE SC-MOVEMENT-SURGERY (AND RELATED INDICATING IF HARM OCCURRED) AND TAKING THE NUMBER OF DEVICES DISTRIBUTED WITHIN EACH TIME PERIOD. THE INCIDENT THAT IS THE SUBJECT OF THIS REPORT IS ALSO INCLUDED IN THE TABLE ABOVE.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING THE PEELING PROCEDURE, THE SURGEON ATTEMPTED TO OPEN AND CLOSE THE FORCEPS TIP TO GRASP THE MEMBRANE; HOWEVER, THIS FUNCTION WAS NOT POSSIBLE ON TWO DEVICES FROM THE SAME LOT. NO REPORT OF PATIENT/USER HARM. NO REPORT OF PROLONGED OR DELAYED SURGERY.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING THE PEELING PROCEDURE, THE SURGEON ATTEMPTED TO OPEN AND CLOSE THE FORCEPS TIP TO GRASP THE MEMBRANE; HOWEVER, THIS FUNCTION WAS NOT POSSIBLE ON TWO DEVICES FROM THE SAME LOT. NO REPORT OF PATIENT/USER HARM. NO REPORT OF PROLONGED OR DELAYED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178497 DISPOSABLE MICROFORCEPS: ILM.(23 GAUGE / 0.6 MM) OPHTHALMIC SOFT-TISSUE SURGICAL FORCEPS, PROBE-LIKE, SINGLE-USE HNR D.O.R.C. DUTCH OPTHALMIC RESEARCH CENTER INT. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown