BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEIN MEDICAL

    MDR report key: 9176998 · Received October 10, 2019

    Report

    Report Number
    2242450-2019-00001
    Event Type
    Injury
    Date Received
    October 10, 2019
    Date of Event
    May 31, 2019
    Report Date
    October 10, 2019
    Manufacturer
    KATENA PRODUCTS, INC
    Product Code
    HND
    UDI-DI
    00852979003397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THAT THE TIP HAD BROKEN OFF AND THAT THE BREAK OCCURRED AT A LOCATION THAT WOULD REQUIRE EXCESSIVE FORCE TO BREAK. THIS EXCESSIVE FORCE IS MORE THAN WOULD BE EXPECTED DURING NORMAL CATARACT PHACOEMULSIFICATION SURGERY. THIS SUGGESTS THAT THE INSTRUMENT WAS MOST LIKELY EXPOSED TO EXCESSIVE FORCE PRIOR TO ITS USE IN SURGERY, WHEREBY, THE STRUCTURAL INTEGRITY OF THE METAL WAS COMPROMISED AND ULTIMATELY CONTRIBUTED TO THE BREAKAGE. REVIEW OF THE MANUFACTURER'S COMPLAINT HANDLING SYSTEM DATABASE CONFIRMS THIS TO BE THE FIRST REPORT OF THIS NATURE FOR THIS DEVICE (MODEL NUMBER 08-145278). THE INSTRUMENT HAS BEEN IN COMMERCIAL DISTRIBUTION FOR SEVERAL YEARS WITHOUT INCIDENT OR COMPLAINT. THE SURGEON REPORTED THAT HE TOOK THE TIP OUR DURING THE SURGERY, THAT THERE WAS NO INJURY TO THE PATIENT AND NO PROLONGED HOSPITALIZATION REQUIRED.

    Description of Event or Problem · 1

    DURING PHACOEMULSIFICATION CATARACT SURGERY THE TIP OF AN OPHTHALMIC CHOPPER BROKE OFF IN THE PATIENT'S EYE. THE SURGEON REMOVED THE BROKEN TIP DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968036 RHEIN MEDICAL SHEPPARD TOMAHAWK CHOPPER RIGHT HAND DOMINANT HND KATENA PRODUCTS, INC 08-14527 N/A 00852979003397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention