BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA VITRECTOMY PACK VGPC INPUT 25G

    MDR report key: 12273500 · Received August 4, 2021

    Report

    Report Number
    1222074-2021-00060
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    May 21, 2021
    Report Date
    September 16, 2021
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN REGARDS TO THIS EVENT, TWO EVA CARTRIDGES WERE RETURNED FOR INVESTIGATION. INVESTIGATION OF THE RETURNED PRODUCTS REVEALED NO ANOMALIES. ALSO NO PROBLEMS OCCURRED DURING TESTING. THEREFORE THE EVENT CANNOT BE ATTRIBUTED TO THE RETURNED CARTRIDGES. POSSIBLY, THE REPORTED EVENT IS ATTRIBUTABLE TO THE PUMP MODULE SUBJECT TO THE EVENT. PLEASE BE INFORMED THAT THE PUMP MODULE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4) / NCA REFERENCE NUMBER 1222074-2021-00048. THE CURRENT COMPLAINT IS CONSIDERED A DUPLICATE OF (B)(4) BUT THIS WAS NOT PREVIOUSLY IDENTIFIED AS DIFFERENT PRODUCTS WERE REFERENCED. 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT DURING PROCEDURE THE MACHINE GAVE AN ERROR MESSAGE. THE USER WAS UNABLE TO SOLVE THE ERROR AND IT WAS DECIDED TO ABORT THE SURGERY. IT IS YET UNKNOWN IF GENERAL ANESTHETIC WAS ADMINISTERED. NO PATIENT HARM OCCURRED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS UNDER INVESTIGATION. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED AT THIS POINT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING PROCEDURE THE MACHINE GAVE AN ERROR MESSAGE. THE USER WAS UNABLE TO SOLVE THE ERROR AND IT WAS DECIDED TO ABORT THE SURGERY. IT IS YET UNKNOWN IF GENERAL ANESTHETIC WAS ADMINISTERED. NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171556 EVA VITRECTOMY PACK VGPC INPUT 25G SURGICAL PACKS AND KITS HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000419253

    Patients

    Seq Age Sex Outcome Treatment
    1