BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIESHABER REVOLUTION DSP FORCEPS

    MDR report key: 11922956 · Received June 2, 2021

    Report

    Report Number
    3003398873-2021-00035
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 8, 2021
    Report Date
    June 2, 2021
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    UDI-DI
    07612717070622
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    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 NURSE REPORTED THAT DURING A VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS COULD NOT BE OPENED AFTER IT WAS CLOSED. THE SURGERY WAS COMPLETED BY USING A NEW PRODUCT. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT A TOTAL OF THREE FORCEPS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820933 GRIESHABER REVOLUTION DSP FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG NA F186627 07612717070622

    Patients

    Seq Age Sex Outcome Treatment
    1