BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREPHINE VACUUM 8.0 MM

    MDR report key: 10641440 · Received October 7, 2020

    Report

    Report Number
    10641440
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 25, 2020
    Manufacturer
    JEDMED INSTRUMENT COMPANY
    Product Code
    HRH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TREPHINE FAILED TO HOLD SUCTION TO CUT AND REMOVE THE PATIENT'S CORNEA. ANOTHER TREPHINE WAS USED TO COMPLETE THE PROCEDURE. PRODUCT HAS PATIENT CONTACT BUT NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107545 TREPHINE VACUUM 8.0 MM TREPHINE, MANUAL, OPHTHALMIC HRH JEDMED INSTRUMENT COMPANY 21-8280 20029219

    Patients

    Seq Age Sex Outcome Treatment
    1 30660 DA