BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KATENA PRODUCTS, INC

    MDR report key: 11641011 · Received April 9, 2021

    Report

    Report Number
    2242450-2021-00001
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 9, 2021
    Product Code
    HNQ
    UDI-DI
    00852979003304
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INSTRUMENT WAS VISUALLY INSPECTED UNDER A MICROSCOPE AND COMPARED TO THE MASTER MODEL. THERE IS NO EVIDENCE OF MATERIAL DEFECT OR MANUFACTURING ERROR. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THE DEVICE. THE INSTRUMENT APPEARS TO HAVE BEEN DAMAGED PRIOR TO BREAKING. THE CAUSE OF INSTRUMENT TIP BREAKAGE COULD NOT BE DETERMINED BECAUSE THE BROKEN TIP WAS NOT RETUNED FOR EVALUATION. THE USER FACILITY INDICATED THAT THERE WAS NO INJURY TO THE PATIENT. AFTER THE TIP BROKE OFF, THE SURGEON IMMEDIATELY RETRIEVED THE TIP FROM PATIENT'S EYE WITH NO COMPLICATIONS. NO PROLONGED SURGERY OR HOSPITALIZATION WAS REQUIRED. THE PATIENT'S POST-OP VISIT THE FOLLOWING DAY WENT WELL, NO COMPLAINTS OR COMPLICATIONS REPORTED, AND NO FURTHER RECOMMENDATIONS.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION WITH IOL IMPLANT PROCEDURE THE TIP OF THE NAGAHARA PHACO CHOPPER BROKE OFF IN THE PATIENT'S EYE. THE SURGEON IMMEDIATELY RETRIEVED THE TIP WITH NO COMPLICATIONS AND NO INJURY TO THE PATIENT WAS REPORTED. NO PROLONGED SURGERY OR HOSPITALIZATION WAS REQUIRED. THE PATIENT'S POST-OP VISIT THE FOLLOWING DAY WENT WELL, NO COMPLAINTS OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538969 KATENA PRODUCTS, INC NAGAHARA PHACO CHOPPER HNQ 08-14502 NA 00852979003304

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention