BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA TDC VITRECTOMY PACK VGPC INPUT 25G

    MDR report key: 15454744 · Received September 20, 2022

    Report

    Report Number
    1222074-2022-00068
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    September 13, 2022
    Report Date
    November 1, 2022
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN REGARD TO THIS COMPLAINT, THREE TROCARS WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED NO ANOMALIES; HOWEVER, TESTING CONFIRMED THAT TWO OF THE CLOSURE VALVES WERE IN FACT LEAKING. DESPITE THE OBSERVED LEAKAGE, CLOSE EXAMINATION OF THE CLOSURE VALVES SHOWED NO SIGNS OF DAMAGE. THOUGH THERE SEEMED TO BE NO VISUAL DEFICIENCIES TO THE VALVES, IT IS VERY WELL POSSIBLE THAT THE VALVES WERE INITIALLY STUCK TO THE INSERTERS. DUE TO SUCH AN ADHESION, THE VALVE MAY NOT CLOSE COMPLETELY UPON REMOVAL OF THE INSERTER AND LEAKAGE IS FACILITATED. DUE TO A RECENT INCREASE OF SIMILAR COMPLAINTS, A BROADER INVESTIGATION AS TO THE CAUSE OF THIS FAILURE HAS BEEN INITIATED. 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. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VITRECTOMY PROCEDURE IT WAS NOTICED THAT THE CLOSURE VALVE WAS LEAKING. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VITRECTOMY PROCEDURE IT WAS NOTICED THAT THE CLOSURE VALVE WAS LEAKING. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698801 EVA TDC VITRECTOMY PACK VGPC INPUT 25G SURGICAL PACKS & KITS HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000435592

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown