BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA VITRECTOMY TDC KIT 2-STEP 23G

    MDR report key: 16334403 · Received February 9, 2023

    Report

    Report Number
    1222074-2023-00005
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 23, 2023
    Report Date
    April 3, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    QDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN REGARD TO THIS COMPLAINT, TWO INSERTERS WITH PROTECTION CAPS WERE RECEIVED AT DORC. UNFORTUNATELY, SINCE THE INVOLVED CANNULAS WERE NOT RETURNED, A PHYSICAL EXAMINATION AS TO THE POSSIBLE CAUSE OF THE REPORTED FAILURE COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS AND A DATABASE SEARCH SHOWED THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ON THIS SPECIFIC LOT PREVIOUSLY. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. SINCE THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES AND BECAUSE NO ASSIGNABLE CAUSE OF FAILURE COULD BE DETERMINED, FURTHER ACTIONS ARE DEEMED NOT REQUIRED AT THIS POINT. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODE CI-CANN-EJECTED RELATED TO COMPARABLE TROCAR SYSTEMS. PLEASE NOTE: THIS CASE WAS SUBMITTED TO THE FDA BY ERROR. CONCERNED PRODUCT 8500.23G2T IS NOT AVAILABLE ON THE US MARKET.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT WHEN PULLING OUT THE TROCAR INSERTERS, THE TROCAR CAME OUT OF THE EYE ALONGSIDE THE INSERTER. THE SURGEON REPORTED SEEING SOME PARTICLES STUCK TO THE VALVE. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT WHEN PULLING OUT THE TROCAR INSERTERS, THE TROCAR CAME OUT OF THE EYE ALONGSIDE THE INSERTER. THE SURGEON REPORTED SEEING SOME PARTICLES STUCK TO THE VALVE. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411736 EVA VITRECTOMY TDC KIT 2-STEP 23G SURGICAL PACKS AND KITS QDY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000439393

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown