BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIM DOUBLE CHOPPER

    MDR report key: 21955065 · Received May 2, 2025

    Report

    Report Number
    2242450-2025-00003
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    March 10, 2025
    Report Date
    June 3, 2025
    Manufacturer
    KATENA PRODUCTS INC.
    Product Code
    HND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER STATED THAT THE INSTRUMENTS WILL BE RETURNED TO KATENA FOR EVALUATION. AT THE TIME OF THIS REPORT, NO INSTRUMENTS HAVE BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS BEING SUBMITTED AS AN UPDATE FOR 2242450-2025-00003 (KIM DOUBLE CHOPPER K3-2335, LOT L2411J00006477). UPDATE FROM THE SURGEON INDICATES THAT THE INSTRUMENTS FAILED IN TWO SEPARATE PROCEDURES. IT IS UNKNOWN. AS OF 03-JUN-2025, NO INSTRUMENTS HAVE BEEN RECEIVED BY KATENA FOR EVALUATION. CORZA HAS MADE MULTIPLE ATTEMPTS TO RETRIEVE THE INSTRUMENTS. REVIEW OF PAST COMPLAINTS AGAINST K3-2335 INDICATES THAT THIS IS THE 4TH COMPLAINT TOTAL AGAINST THIS PRODUCT. THIS IS THE 3RD COMPLAINT CLAIMING THAT THE INSTRUMENT BROKE. THERE WERE (B)(4) UNITS MANUFACTURED IN THIS LOT. THIS IS THE FIRST COMPLAINT REPORTED AGAINST THIS LOT.

    Description of Event or Problem · 0

    ON 03-APR-2025, A DISTRIBUTOR FROM POLAND INFORMED KATENA PRODUCTS INC. (A CORZA MEDICAL COMPANY) CUSTOMER SERVICE REPRESENTATIVE THAT SHE RECEIVED A COMPLAINT FROM ONE OF THEIR CUSTOMERS AGAINST K3-2335 KIM DOUBLE CHOPPER FROM KATENA. THEIR CUSTOMER RETURNED THREE (3) UNITS TO THE DISTRIBUTOR CLAIMING THAT THE TIP OF THE INSTRUMENTS ARE BREAKING WHILE MANIPULATING IN THE EYE DURING CATARACT SURGERY. THE REPORTER STATED THAT THE INCIDENT OCCURRED ON (B)(6) 2025. THE INSTRUMENTS' LOTS ARE L2411J00006477, L2406J000057382, L2405J000056218. THE DISTRIBUTOR ALSO STATED THAT THEIR CUSTOMER IS IN POSSESSION OF TWO (2) MORE INSTRUMENTS WHERE A SIMILAR INCIDENT OCCURED, HOWEVER THERE WERE NO LOT NUMBERS OR ADDITIONAL DETAILS PROVIDED. THERE WERE NO INJURIES OR HARM TO THE PATIENT. THE BROKEN PIECE WAS "GENTLY REMOVED" ACCORDING TO THE REPORTER OF THE INCIDENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE DISTRIBUTOR AND DOCTOR INVOLVED. KATENA REQUESTED THAT THE INSTRUMENTS BE SENT BACK TO RANDOLPH, NJ FOR A FULL INVESTIGATION. NO ITEMS HAVE BEEN RECEIVED AT THE TIME OF THIS REPORT. 4 INDIVIDUAL REPORTS WILL BE SUBMITTED TO CAPTURE INSTRUMENT LOTS L2411J00006477, L2406J000057382, L2405J000056218, AND UNKNOWN LOT AS IT IS UNCLEAR HOW MANY INCIDENTS OR PATIENTS INVOLVING THE INSTRUMENTS OCCURED. THIS REPORT IS INTENDED TO CAPTURE LOT L2411J00006477.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024083 KIM DOUBLE CHOPPER SPATULA, OPHTHALMIC HND KATENA PRODUCTS INC. K3-2335 L2411J000064777

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown