BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA

    MDR report key: 11645568 · Received April 9, 2021

    Report

    Report Number
    1222074-2021-00023
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 14, 2021
    Report Date
    May 21, 2021
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WITH REGARD TO THIS EVENT, AN EVA VITRECTOMY MODULE WAS RETURNED FOR INVESTIGATION. INVESTIGATION OF THE RETURNED MODULE REVEALED THAT ONE OF THE CUTTER VALVES FAILED AND WAS STUCK IN A CLOSED POSITION. THOUGH THE EVA SYSTEM WILL PASS THE PRIMING PHASE, THE CUTTER WILL NOT BE ACTIVATED BECAUSE THE VALVE IS STUCK IN THE CLOSED POSITION. A DHR REVIEW DID NOT REVEAL ANY ANOMALIES AND THE PRODUCT WAS RELEASED ACCORDING TO ITS RELEASE SPECIFICATIONS. ALSO A HISTORICAL REVIEW OF THE COMPLAINT DATABASE INDICATED THAT NO SIMILAR COMPLAINTS HAVE BEEN LOGGED ON THE EVA SURGICAL SYSTEM SUBJECT TO THIS REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THIS EVENT OCCURRED DUE TO A RANDOM COMPONENT FAILURE OF A VALVE INSIDE THE VITRECTOMY MODULE. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. THEREFORE, NO REMEDIAL OR CORRECTIVE/PREVENTIVE ACTIONS WILL BE UNDERTAKEN AT THIS MOMENT. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. THEREFORE, NO REMEDIAL OR CORRECTIVE/PREVENTIVE ACTIONS WILL BE UNDERTAKEN AT THIS MOMENT. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE IMPLEMENTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS NO ACTIVATION OF THE VITRECTOME AND A SLIGHT NOISE WAS COMING FROM THE VITRECTOMY MODULE. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT IS BEING RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS NO ACTIVATION OF THE VITRECTOME AND A SLIGHT NOISE WAS COMING FROM THE VITRECTOMY MODULE. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543662 EVA PHACOEMULSIFICATION/VITRECTOMY SYSTEM HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.

    Patients

    Seq Age Sex Outcome Treatment
    1