BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K5-2500 CASTROVIEJO FORCEPS 0.12MM

    MDR report key: 23149710 · Received September 25, 2025

    Report

    Report Number
    3010692967-2025-00076
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Report Date
    September 25, 2025
    Manufacturer
    CORZA OPTHALMOLOGY (KATENA PRODUCTS INC.)
    Product Code
    HTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH IT REMAINS UNCLEAR WHETHER THE DISCOLORATION IN THE SUBMITTED IMAGE IS RUST, THIS REPORT IS BEING FILED DUE TO CONCERNS THAT THE UNIDENTIFIED PHENOMENON MAY INCREASE THE RISK OF INFECTION. THE REPORTER NOTED THAT NO CLEARER IMAGE OF THE AFFECTED INSTRUMENT IS AVAILABLE AND INSTEAD PROVIDED A PHOTO OF A SEPARATE INSTRUMENT EXHIBITING A SIMILAR ISSUE. THE IMAGE SHOWS DISCOLORATION RATHER THAN RUST AT THE TIP. CORZA HAS PROVIDED THE CUSTOMER WITH THE OFFICIAL CARE AND HANDLING GUIDE, WHICH OUTLINES THE DIFFERENCES BETWEEN RUST AND DISCOLORATION ON STAINLESS STEEL INSTRUMENTS AND OFFERS GUIDANCE ON PREVENTION. THE REPORTER CONFIRMED THAT THE SUSPECTED INSTRUMENT WILL NOT BE RETURNED FOR EVALUATION, AND NO LOT NUMBER WAS PROVIDED. ADDITIONALLY, THE USER CLAIMED THAT THE DISCOLORATION WAS OBSERVED BEFORE THE INSTRUMENT CAME INTO CONTACT WITH THE PATIENT, AND THE INSTRUMENT WAS NEVER USED. A REVIEW OF PAST COMPLAINTS INDICATES THAT RUST TYPICALLY RESULTS FROM IMPROPER CLEANING AND STORAGE PRACTICES. DISCOLORATION MAY OCCUR WHEN UNAPPROVED DETERGENTS ARE USED DURING THE CLEANING PROCESS. THE INSTRUMENT'S VALIDATED INSTRUCTIONS FOR USE (IFU LT-2) INCLUDE DETAILED GUIDANCE ON APPROVED CLEANING AGENTS AND PROCEDURES. THE IFU ALSO STATES THAT THE INSTRUMENT SHOULD BE THOROUGHLY INSPECTED PRIOR TO USE.

    Description of Event or Problem · 0

    ON AUGUST 26, 2025, A DISTRIBUTOR FROM THAILAND CONTACTED CORZA CUSTOMER SERVICE VIA EMAIL TO INQUIRE ABOUT POTENTIAL CAUSES OF RUST ON STAINLESS STEEL INSTRUMENTS. THE EMAIL INCLUDED AN IMAGE SHOWING A K5-2500 CASTROVIEJO FORCEPS IN USE DURING A PROCEDURE. THE PHOTO WAS CAPTURED FROM A VIDEO MONITOR DISPLAYING THE LIVE FEED FROM THE DOCTOR'S SCOPE. ALTHOUGH THE IMAGE IS BLURRY, SLIGHT DISCOLORATION IS VISIBLE ON THE INSTRUMENT'S JAW, WHICH MAY RESEMBLE RUST. CORZA REQUESTED A CLEARER IMAGE FROM THE CUSTOMER AND ASKED THAT THE INSTRUMENT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323410 K5-2500 CASTROVIEJO FORCEPS 0.12MM CASTROVIEJO FORCEPS HTD CORZA OPTHALMOLOGY (KATENA PRODUCTS INC.) K5-2500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown