BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIESHABER ULTRASHARP KNIFE

    MDR report key: 11889170 · Received May 26, 2021

    Report

    Report Number
    3003398873-2021-00033
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNN
    UDI-DI
    07612717000063
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TIP OF TWO KNIVES WERE NOT AS SHARP AS USUAL. PROCEDURE DETAILS INFORMATION IS UNKNOWN. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT OR PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784771 GRIESHABER ULTRASHARP KNIFE KNIFE, OPHTHALMIC HNN ALCON GRIESHABER AG NA F190610 07612717000063

    Patients

    Seq Age Sex Outcome Treatment
    1