BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAGAHARA PHACO CHOPPER

    MDR report key: 15446614 · Received September 19, 2022

    Report

    Report Number
    2242450-2022-00002
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 2, 2022
    Report Date
    September 27, 2022
    Manufacturer
    KATENA PRODUCTS INC.
    Product Code
    HND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS BEING SUBMITTED BECAUSE THE INSTRUMENT HAS BEEN RETURNED FOR EVALUATION. THE CHANGES AND ADDITIONAL INFORMATION IN THIS FOLLOW UP IS INTENDED TO REFLECT THE EVALUATION OF THE RETURNED INSTRUMENT. SECTION H3 UPDATED TO 'YES'. SECTION H6 CHANGES: REMOVED CODE 4580 FROM 'CLINICAL CODE', REMOVED CODE 4114 AND ADDED CODE 10 TO 'TYPE OF INVESTIGATION'. COMPLAINT SAMPLE WAS RECEIVED ON 16-SEP-2022. MAGNIFIED VISUAL ASSESSMENT WAS PERFORMED. IT SEEMS THAT CRACK WAS INITIATED, PROPAGATED, AND FINALLY FRACTURED DUE TO OVERLOAD ON A SIGNIFICANTLY REDUCED CROSS-SECTION OF THE TIP. IT IS UNKNOWN WHEN THE INITIAL DAMAGE TO THE CHOPPER OCCURRED, HOWEVER THE NATURE OF THE PROCEDURE AND USER'S TECHNIQUE MAY HAVE HAD AN AFFECT ON THE INSTRUMENT. PHACO PROCESS GENERATES CYCLIC PULSES WITH HIGH ENERGY, AND MAY INDUCE THE ABOVE-MENTIONED FAILURE MECHANISMS WHEN IT IS IN CLOSE PROXIMITY OF THE CHOPPER.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY REPORTED TO KATENA'S AUSTRALIA DISTRIBUTOR THAT HALFWAY THROUGH QUADRANT REMOVAL OF THE NUCLEUS, THE NAGAHARA PHACO CHOPPER TIP BROKE OFF. THE PHACOEMULSIFICATION PROBE WAS ALSO IN USE DURING THE EVENT, HOWEVER THE REPORTER STATED THAT THERE WAS NO CONTACT BETWEEN THE TWO INSTRUMENTS. REPORTER STATED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE DETACHED INSTRUMENT TIP WAS REMOVED IMMEDIATELY. AS A RESULT, THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY THREE MINUTES. THE USER FACILITY INDICATED THAT THE PATIENT IS IN "GOOD CONDITION" AND RECOVERING WELL POST-SURGERY. THE INSTRUMENT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HISTORICAL DATA WAS REVIEWED AND CORZA OPTHALMOLOGY WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINT TRENDS WITH THIS PARTICULAR INSTRUMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A DISTRIBUTOR IN AUSTRALIA REPORTED THAT ON (B)(6) 2022 A NAGAHARA PHACO CHOPPER K3-2329 TIP BROKE OFF DURING CATARACT SURGERY. NO PATIENT HARM WAS REPORTED, HOWEVER ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT INJURY. ADDITIONAL VISCOELASTIC INJECTION WAS GIVEN TO IMMOBILIZE THE PIECE AND A PAIR OF INTRAOCCULAR FORCEPS WAS USED TO REMOVE THE BROKEN TIP. AS A RESULT, THE PROCEDURE WAS LENGTHENED BY THREE ADDITIONAL MINUTES. REPORTER STATED THAT A PHACOEMULSIFICATION PROBE WAS ALSO IN USE DURING THE INCIDENT, HOWEVER NO CONTACT BETWEEN THE TWO INSTRUMENTS. KATENA PRODUCTS INC. REQUESTED THAT THE INSTRUMENT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250109 NAGAHARA PHACO CHOPPER SPATULA HND KATENA PRODUCTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown