BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA NEXUS¿ COMBINED 25G TDC PACK

    MDR report key: 17037393 · Received June 1, 2023

    Report

    Report Number
    1222074-2023-00046
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 25, 2023
    Report Date
    September 21, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. NO CORRECTIVE OR PREVENTIVE ACTIONS CAN BE IMPLEMENTED UNTIL THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE IS NOT ACCESSIBLE FOR INVESTIGATION YET. THE INVESTIGATION WILL BE CONTINUED WHEN THE DEVICE IS AVAILABLE FOR EXAMINATION.

    Additional Manufacturer Narrative · 0

    UNFORTUNATELY, THE INVOLVED TROCARS WERE NOT RECEIVED. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS AND A DATABASE SEARCH SHOWED THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ON THIS SPECIFIC LOT PRIOR TO THIS CASE OR SINCE. THOUGH NO SIMILAR COMPLAINTS WERE REPORTED ON THIS LOT, LEAKAGE IS CONSIDERED A KNOWN ISSUE WITH THE AVETA TROCAR. DUE TO AN INCREASE OF SIMILAR COMPLAINTS IN 2022, AN INVESTIGATION AS TO THE CAUSE OF THIS TYPE OF FAILURE WAS INITIATED. THOUGH THE INVESTIGATION LEAD TO AN INITIAL CORRECTIVE ACTION THAT PREVENTS MOST OCCURRENCES, IT DID NOT COMPLETELY ELIMINATE THE ISSUE. PLEASE NOTE THAT A THOROUGH INVESTIGATION TO DETERMINE FURTHER ACTIONS TO IMPROVE THE AVETA TROCAR IS CURRENTLY ONGOING. AN INCREASE IN COMPLAINT RATE WAS OBSERVED IN 2022, WHICH TRIGGERED A DETAILED INVESTIGATION OF THE MANUFACTURING PROCESS. AS A RESULT THE DRYING TIME WAS INCREASED, AS THIS WAS CONSIDERED THE CAUSE OF THE INCREASE IN COMPLAINTS OBSERVED. THOUGH THE CORRECTIVE ACTION PREVENTS MOST OCCURRENCES, IT DID NOT COMPLETELY ELIMINATE THE ISSUE. A THOROUGH INVESTIGATION TO DETERMINE FURTHER ACTIONS TO IMPROVE THE AVETA TROCAR IS CURRENTLY ONGOING. PER ECF 2022-390, A CHANGE WAS INITIATED TO INCREASE THE DRYING TIME BETWEEN GLUE APPLICATION AND NEXT STEPS OF ASSEMBLY. THE CHANGE WAS IMPLEMENTED WITH AN UPDATE OF ALL RELEVANT WORK INSTRUCTIONS. AS OF 07OCT22 ALL AVETA TROCARS ARE ASSEMBLED IN ACCORDANCE WITH THE UPDATED WORK INSTRUCTIONS. SINCE THE CORRECTIVE ACTION DID NOT COMPLETELY ELIMINATE THE ISSUE. A THOROUGH INVESTIGATION TO DETERMINE FURTHER ACTIONS TO IMPROVE THE AVETA TROCAR IS CURRENTLY ONGOING UNDER DTP 2023-249 AVETA IMPROVEMENTS. THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODES CI-CLOSUREVALVE-LEAKAGE, CI-INF-LEAKAGE AND CI-CLOSUREVALVE-DEFECT-REMOVAL RELATED TO COMPARABLE TROCAR SYSTEMS. PLEASE NOTE THAT WHILE THE 2023 INCIDENT NUMBERS ARE UP TO DATE, THE 2023 DISTRIBUTION FIGURES ARE FROM (B)(6) 2023. AS THESE PRODUCTS ARE STILL BEING DISTRIBUTED, THE ACTUAL NUMBER OF DEVICES IN THE MARKET IS HIGHER. THE INCIDENT RATE IS THEREFORE IN FACT LOWER.

    Additional Manufacturer Narrative · 0

    IN CASE OF A PRODUCT RETURN, THE DEVICE WILL BE INVESTIGATED, OTHERWISE WE WILL REVIEW THE DEVICE HISTORY RECORD, AND/OR ANY LOG FILES IF AVAILABLE, OR TRY TO REPLICATE THE PROBLEM ON SIMILAR PRODUCT. AS INVESTIGATIONS ON THE ACTUAL PRODUCT OR REPRESENTATIVE SAMPLE OF A BATCH MAY ALTER THE DEVICE, WE REQUEST TO INFORM US WITHIN 7 DAYS AFTER SUBMISSION OF THIS REPORT, IN CASE THE INVESTIGATIONS THAT ALTER THE DEVICE SHOULD BE HALTED UNTIL APPROVAL OF THE NCA, AS PER ARTICLE 89 OF EU-MDR.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, THE TROCAR STARTED LEAKING AIR. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, THE TROCAR STARTED LEAKING AIR. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, THE TROCAR STARTED LEAKING AIR. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160192 EVA NEXUS¿ COMBINED 25G TDC PACK SURGICAL PACKS AND KITS HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. 2000443225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown