BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSERTER

    MDR report key: 18788288 · Received February 23, 2024

    Report

    Report Number
    MW5152006
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 20, 2024
    Report Date
    February 21, 2024
    Manufacturer
    CORNEAGEN, INC.
    Product Code
    OTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CORNEAGEN'S ENDOSERTER DEVICE DID NOT CORRECTLY DEPLOY WHEN UTILIZED BY THE SURGEON. THE SURGEON SUBSEQUENTLY HAD TO MANUALLY INSERT THE CORNEA FOR TRANSPLANT. THERE WAS NO HARM TO THE PATIENT. PRODUCT # ES-1. LOT #: 04032302. PRODUCT EXPIRATION DATE: 5/31/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926892 ENDOSERTER GRAFT INSERTION INSTRUMENT FOR ENDOTHELIAL KERATOPLASTY OTZ CORNEAGEN, INC. ES-1 04032302

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male