BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA

    MDR report key: 11748991 · Received April 29, 2021

    Report

    Report Number
    1222074-2021-00031
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 31, 2021
    Report Date
    June 9, 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 REGARDS TO THIS EVENT, AN EVA VITRECTOMY MODULE WAS RECEIVED FOR INVESTIGATION. INVESTIGATION OF THE RETURNED MODULE REVEALED THAT ONE OF THE CUTTER VALVES FAILED AND DID NOT CLOSE AND OPEN CORRECTLY, SINCE THE VALVE WAS STICKING FROM TIME TO TIME . THIS RESULTED IN THE FACT THAT THE CUTTER WILL NOT BE ACTIVATED CONSISTENTLY AND CAUSED THE REPORTED SOUND. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE INDICATED THAT A SIMILAR COMPLAINT HAS BEEN LOGGED ON THE EVA SURGICAL SYSTEM LAST YEAR, HOWEVER, AT THAT TIME THE VITRECTOMY MODULE WAS NOT RETURNED FOR INVESTIGATION. NO OTHER SIMILAR COMPLAINTS WERE LOGGED ON THE EVA SURGICAL SYSTEM SUBJECT TO THIS REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, IT IS CONCLUDED 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS NO ACTIVATION OF THE VITRECTOME AND A SLIGHT NOISE WAS COMING FROM THE VITRECTOMY MODULE. DUE TO THIS EVENT THE PROCEDURE WAS DELAYED >30MINUTES. NO ACTUAL PATIENT HARM OCCURED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT HAS BEEN 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. DUE TO THIS EVENT THE PROCEDURE WAS DELAYED >30 MINUTES. NO ACTUAL PATIENT HARM OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647150 EVA PHACOEMULSIFICATION/VITRECTOMY SYSTEM HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.

    Patients

    Seq Age Sex Outcome Treatment
    1