BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA NEXUS¿ POSTERIOR 25G TDC PACK

    MDR report key: 17246514 · Received July 3, 2023

    Report

    Report Number
    1222074-2023-00052
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 28, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN REGARD TO THIS COMPLAINT, TWO CANNULA'S WITH CLOSURE VALVES WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED NO ANOMALIES; HOWEVER, TESTING DEMONSTRATED THAT LEAKAGE FROM ONE OF THE CLOSURE VALVES EXCEEDED THE ALLOWED MAXIMUM OF 0.4 ML/MIN AT 40 MMHG. THE OTHER VALVE DID MEET THE SPECIFICATION. DESPITE THE OBSERVED LEAKAGE, CLOSE EXAMINATION OF THE CLOSURE VALVES SHOWED NO SIGNS OF DAMAGE. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS. 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, THOUGH THE COMPLAINT NUMBERS ARE CORRECT, THE SALES FIGURES HAVE ONLY BEEN UPDATED UNTIL THE END OF MAY DUE TO A NEW ERP SYSTEM. HENCE, THE TABLE IN FACT SHOWS A WORST CASE SCENARIO.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, THE TROCAR WAS LEAKING AND THE SURGEON HAD TO WIPE OFF THE BUBBLES. 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 WAS LEAKING AND THE SURGEON HAD TO WIPE OFF THE BUBBLES. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20756 EVA NEXUS¿ POSTERIOR 25G TDC PACK SURGICAL PACKS AND KITS HQE D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. 2000444404

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown