BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G CANNULA SET WITH HIGH FLOW INFUSION LINE

    MDR report key: 16218891 · Received January 20, 2023

    Report

    Report Number
    1222074-2023-00002
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 4, 2023
    Report Date
    March 14, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    NGY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNFORTUNATELY, THE INVOLVED TROCARS WERE NOT RETURNED. HENCE, NO PHYSICAL EXAMINATION COULD BE PERFORMED. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS. PLEASE NOTE THAT, DUE TO A RECENT INCREASE OF CLOSURE VALVE RELATED COMPLAINTS ON THE AVETA TROCAR IN 2022, A BROADER INVESTIGATION WAS INITIATED. A DETAILED INVESTIGATION OF THE MANUFACTURING PROCESS REVEALED THAT WHEN IN THE MANUFACTURING PROCESS THE DRYING TIME OF THE APPLIED GLUE ON THE CAP OF THE PRODUCT IS TOO SHORT FOR THE VOLUME OF GLUE DISPENSED, VALVES MAY IN SOME CASES BECOME STICKY. AS A RESULT OF THE INVESTIGATION THE DRYING TIME OF GLUE WAS INCREASED TO PREVENT RE-OCCURRENCE OF THIS MALFUNCTION GOING FORWARD. IN 2022 AN INCREASE IN COMPLAINT RATE WAS OBSERVED, WHICH TRIGGERED A DETAILED INVESTIGATION OF THE MANUFACTURING PROCESS. AS A RESULT THE DRY TIME WAS INCREASED, AS THIS WAS CONSIDERED THE CAUSE OF THE INCREASE IN COMPLAINTS OBSERVED. 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.THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODES CI-CLOSUREVALVE-LEAKAGE AND CI-CLOSUREVALVE-DEFECT-REMOVAL RELATED TO COMPARABLE TROCAR SYSTEMS.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. NO CORRECTIVE OR PREVENTIVE ACTIONS CAN BE IMPLEMENTED UNTIL THE INVESTIGATION HAS BEEN COMPLETED. 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 THE SEALING CAPS OF THE 23G AVETA TROCAR CANNULAS 1272.ED23 ARE LEAKING, AND THAT IN A COMBINED OPERATION, WHEN THE TROCARS ARE INSERTED BEFOREHAND AND THE LENS REMOVAL IS PERFORMED AFTERWARDS, THE LENS MOVES FORWARD BECAUSE OF THE LEAK. THIS HAS BEEN MORE COMMON IN THE LAST FEW DAYS WITH LOT NUMBER 2000436660. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT THE SEALING CAPS OF THE 23G AVETA TROCAR CANNULAS 1272.ED23 ARE LEAKING, AND THAT IN A COMBINED OPERATION, WHEN THE TROCARS ARE INSERTED BEFOREHAND AND THE LENS REMOVAL IS PERFORMED AFTERWARDS, THE LENS MOVES FORWARD BECAUSE OF THE LEAK. THIS HAS BEEN MORE COMMON IN THE LAST FEW DAYS WITH LOT NUMBER 2000436660. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005030 23G CANNULA SET WITH HIGH FLOW INFUSION LINE OPHTHALMIC CANNULATION SET, SINGLE-USE NGY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000436660

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown