BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED MEMBRANE SCRAPER

    MDR report key: 7143021 · Received December 22, 2017

    Report

    Report Number
    3003398873-2017-00033
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 7, 2017
    Report Date
    January 2, 2018
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HND
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT AN OPHTHALMIC MEMBRANE SCRAPER WAS DIFFICULT TO INSERT THROUGH THE ENTRY TROCAR DURING VITRECTOMY SURGERY RESULTING IN THE LOOP PORTION DETACHING FROM THE DEVICE INTO THE PATIENT'S EYE. THE DETACHED LOOP WAS DETECTED AND REMOVED FROM THE PATIENT'S EYE DURING THE PROCEDURE. AN ALTERNATE SCRAPER WAS OBTAINED IN ORDER TO COMPLETE THE PROCEDURE. PATIENT IMPACT INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923643 CURVED MEMBRANE SCRAPER SPATULA, OPHTHALMIC HND ALCON GRIESHABER AG NA F145790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other