BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25G CANNULA SET WITH HIGH FLOW INFUSION LINE

    MDR report key: 16617599 · Received March 27, 2023

    Report

    Report Number
    1222074-2023-00028
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    January 30, 2023
    Report Date
    May 15, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    NGY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE INVOLVED TROCAR WAS NOT RETURNED, NO PHYSICAL EXAMINATION COULD BE PERFORMED TO CONFIRM THE REPORTED LEAKAGE AND TO DETERMINE ITS CAUSE. SINCE THE LOT NUMBER OF THE INVOLVED PRODUCT WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW AND A DATABASE SEARCH FOR SIMILAR COMPLAINTS ON THE BATCH WERE NOT POSSIBLE EITHER. PLEASE NOTE THAT, DUE TO AN INCREASE OF CLOSURE VALVE RELATED COMPLAINTS ON THE AVETA TROCAR IN 2022, A BROADER INVESTIGATION WAS INITIATED. SUBSEQUENT TO THE INITIAL INVESTIGATION, A PRELIMINARY CORRECTIVE ACTION WAS IMPLEMENTED IN (B)(6) 2022 TO REDUCE SIMILAR ISSUES. PLEASE NOTE THAT A THOROUGH INVESTIGATION TO DETERMINE FURTHER ACTIONS TO IMPROVE THE AVETA TROCAR IS CURRENTLY ONGOING. 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, AS A PRELIMINARY CORRECTIVE ACTION, 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. A THOROUGH INVESTIGATION TO DETERMINE FURTHER ACTIONS TO IMPROVE THE AVETA TROCAR IS CURRENTLY ONGOING PER ECF 2023-249. THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODES CI-CLOSUREVALVE-LEAKAGE AND CI-CLOSUREVALVE-DEFECT-REMOVAL RELATED TO COMPARABLE TROCAR SYSTEMS (DISTRIBUTION FIGURES UP TO AND INCLUDING 25-04-2023).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. 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.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, THE AIR SET VALUE WAS 30MMHG BUT AIR DID NOT COME FROM THE INSTRUMENT . AFTER THE SURGERY THE SURGEON PLACED THE CANNULA AND HF IN WATER AND AN AIR LEAKAGE WAS CONFIRMED. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, THE AIR SET VALUE WAS 30MMHG BUT AIR DID NOT COME FROM THE INSTRUMENT. AFTER THE SURGERY THE SURGEON PLACED THE CANNULA AND HF IN WATER AND AN AIR LEAKAGE WAS CONFIRMED. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432094 25G CANNULA SET WITH HIGH FLOW INFUSION LINE OPHTHALMIC CANNULATION SET, SINGLE-USE NGY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown