BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G

    MDR report key: 15743498 · Received November 7, 2022

    Report

    Report Number
    1222074-2022-00081
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 19, 2022
    Report Date
    December 21, 2022
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION.

    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. AS OF (B)(6) 2022 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.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING CORE VITRECTOMY PROCEDURE, THE TROCAR CANNULAS (VALVED, BLUE CAP SIDE) WERE LEAKING. SURGERY COULD PROCEED BY REPLACING THE TROCAR CANNULAS. 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 CORE VITRECTOMY PROCEDURE, THE TROCAR CANNULAS (VALVED, BLUE CAP SIDE) WERE LEAKING. SURGERY COULD PROCEED BY REPLACING THE TROCAR CANNULAS. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182425 EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G SURGICAL PACKS AND KITS HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000429896

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown