BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA TDC VITRECTOMY PACK VGPC INPUT 25G

    MDR report key: 16416242 · Received February 22, 2023

    Report

    Report Number
    1222074-2023-00016
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    February 10, 2023
    Report Date
    April 18, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNFORTUNATELY, SINCE THE INVOLVED TROCAR WAS NOT RETURNED, NO PHYSICAL EXAMINATION COULD 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. HOWEVER, BASED ON OTHER SIMILAR COMPLAINTS ON OTHER LOTS OF THIS PRODUCT A DETAILED INVESTIGATION OF THE MANUFACTURING PROCESS REVEALED THAT WHEN 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. SUBSEQUENT TO THE INVESTIGATION, THE DRYING TIME WAS INCREASED AS A CORRECTIVE ACTION TO PREVENT SIMILAR ISSUES. THEREFORE, THE MOST PLAUSIBLE ROOTCAUSE OF THIS COMPLAINT IS CONSIDERED A STICKY VALVE DUE TO INSUFFICIENT DRYING TIME OF GLUE IN RELATION TO THE VOLUME OF GLUE APPLIED. IN 2022 AN INCREASE IN COMPLAINT RATE WAS OBSERVED, WHICH TRIGGERED A DETAILED INVESTIGATION OF THE MANUFACTURING PROCESS. AS A RESULT THE DRY TIME WILL BE 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. 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.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PROCEDURE , THE TROCAR WAS LEAKING THROUGH THE VALVE. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED GREATER THAN 30 MINUTES.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PROCEDURE, THE TROCAR WAS LEAKING THROUGH 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
    1643631 EVA TDC VITRECTOMY PACK VGPC INPUT 25G SURGICAL PACKS AND KITS HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000439340

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown