BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAGAHARA PHACO CHOPPER, RH DOMINANT

    MDR report key: 21944714 · Received May 1, 2025

    Report

    Report Number
    2242450-2025-00002
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    February 18, 2025
    Report Date
    May 1, 2025
    Manufacturer
    KATENA PRODUCTS INC.
    Product Code
    HND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KATENA (A CORZA MEDICAL COMPANY) REACHED OUT TO THE REPORTER AND ATTEMPTED TO OBTAIN THE INSTRUMENT FOR EVALUATION. ON 29-APR-2025, THE REPORTER INFORMED CORZA CUSTOMER SERVICE PERSONNEL THAT THE BROKEN ITEM WAS EITHER MISPLACED OR DISCARDED AND THAT PRODUCT RETURN FOR EVALUATION WILL NOT BE POSSIBLE. NO LOT NUMBER WAS PROVIDED. THERE HAS BEEN NO REPORT OF DISCOMFORT OR PATIENT HARM POST PROCEDURE.

    Description of Event or Problem · 0

    ONE 01-APR-2025, A CORZA SALES TEAM MEMBER WAS INFORMED BY A HEALTH FACILITY IN (B)(6) THAT A RHEIN MEDICAL 08-14502 NAGAHARA PHACO CHOPPER TIP BROKE DURING A CATARACT PROCEDURE ON (B)(6) 2025. THE INSTRUMENT'S LOT IS UNKNOWN. THE SURGEON WAS INITIALLY UNSURE WHETHER OR NOT THE BROKEN PIECE REMAINED IN THE PATIENT'S EYE SO A CT SCAN WAS PERFORMED WHICH REVEALED THAT THE BROKEN PIECE REMAINED IN THE PATIENT'S EYE. THE PATIENT EXPERIENCED NO DISCOMFORT OR INFLAMMATION. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE FOREIGN OBJECT FROM THE PATIENT'S EYE. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT IS RECOVERING WITH NO SYMPTOMS OR DISCOMFORT. CORZA MEDICAL OPENED A COMPLAINT FILE (B)(4) ON 02-APR-2025 TO INVESTIGATE THE INCIDENT. THE BROKEN INSTRUMENT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071908 NAGAHARA PHACO CHOPPER, RH DOMINANT Spatula, ophthalmic HND KATENA PRODUCTS INC. 08-14502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown