BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA VITRECTOMY PACK VGPC INPUT 25G

    MDR report key: 6950567 · Received October 14, 2017

    Report

    Report Number
    1222074-2017-00024
    Event Type
    Malfunction
    Date Received
    October 14, 2017
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    D.O.R.C INTERNATIONAL
    Product Code
    MLZ
    PMA / PMN Number
    K142877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE EXTENSIVELY TESTED VITRECTOOM. OUR R & D DEPARTMENT HAS MADE A CHANGE. AS WAS ALREADY INDICATED IN THE SNF, THE NEW VITRECTOOM WILL SOON BE AVAILABLE. OUR CSC DEPARTMENT CAN TELL WHEN THE NEW SERIES IS AVAILABLE. BUBBLES CAN LEAD TO A PATIENT HARM, HENCE REPORTABLE. PERFORMANCE VARIES IN- AND OUT-OF-SPECIFICATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A VOLUNTARY RETROSPECTIVE REVIEW OF ALL COMPLAINTS SINCE 2015 BY THE MANUFACTURER. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Description of Event or Problem · 1

    TODAY WE FACED A NEW AND VERY SERIOUS ISSUE AND WE ARE TRYING TO UNDERSTAND THE REASONS FOR IT. IT WAS NOTICED BUBBLES FROM THE ASPIRATION PORT OF THE CUTTER AT HIGH CUT RATE-SHAVING MODE. INFORMATION REASONABLY SUGGESTS THAT THIS INCIDENT OCCURRED DURING SURGERY. NO INFORMATION OF PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729987 EVA VITRECTOMY PACK VGPC INPUT 25G EVA VITRECTOMY PACK VGPC INPUT 25G MLZ D.O.R.C INTERNATIONAL 2000358476

    Patients

    Seq Age Sex Outcome Treatment
    1