BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA

    MDR report key: 12578513 · Received October 5, 2021

    Report

    Report Number
    1222074-2021-00069
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    August 31, 2021
    Report Date
    November 16, 2021
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WITH REGARDS TO THIS EVENT, A VITRECTOMY MODULE WAS RECEIVED FOR INVESTIGATION. INVESTIGATION OF THE RETURNED MODULE REVEALED THAT A PARTICLE WAS STUCK IN ONE OF THE VALVES OF THE VITRECTOMY MODULE PREVENTING THE VALVE FROM FUNCTIONING CORRECTLY. BASED UPON THE NATURE OF THE PARTICLE IT WAS DETERMINED THAT THE PARTICLE ORIGINATED FROM AN ASPIRATION TUBING OF A VITRECTOMY CUTTER. THE VITRECTOMY MODULE ITSELF WAS RELEASED ACCORDING TO THE RELEASE SPECIFICATION IN Q2 2016 AND NO ISSUES WERE REPORTED UNTIL THE REPORTED EVENT. THE ROOT CAUSE OF THE PRESENCE OF THE PARTICLE IDENTIFIED WAS RELATED TO THE ASSEMBLY OF ONE OF THE VITRECTOMES USED. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO PREVENT SIMILAR EVENTS FROM OCCURRING, WHERE TREND ANALYSIS INDICATES THAT THE EVA SURGICAL SYSTEM IS PERFORMING WITHIN ANTICIPATED RATES. THEREFORE, NO REMEDIAL ACTIONS OR CORRECTIVE/PREVENTIVE ACTIONS WILL BE UNDERTAKEN AT THIS MOMENT. COMPLAINTS WILL BE MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE THE CUTTER STOPPED WHILE CUTTING SOUNDS WERE COMING FROM THE VITRECTOMY MODULE. THERE WAS NO AIR PRESSURE WHICH WAS LIKELY CAUSED BY THE AIR MODULE BEING BLOCKED. DUE TO THIS EVENT SURGERY WAS PROLONGED >30 MINUTES. NO ACTUAL PATIENT HARM IS REPORTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE THE CUTTER STOPPED WHILE CUTTING SOUNDS WERE COMING FROM THE VITRECTOMY MODULE. THERE WAS NO AIR PRESSURE WHICH WAS LIKELY CAUSED BY THE AIR MODULE BEING BLOCKED. DUE TO THIS EVENT SURGERY WAS PROLONGED >30 MINUTES. NO ACTUAL PATIENT HARM IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472311 EVA PHACOEMULSIFICATION/VITRECTOMY SYSTEM HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown