BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA TDC VITRECTOMY PACK VGPC INPUT 23G

    MDR report key: 16860276 · Received May 3, 2023

    Report

    Report Number
    1222074-2023-00042
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    March 27, 2023
    Report Date
    May 3, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS AND A DATABASE SEARCH SHOWED THAT NO SIMILAR COMPLAINT HAVE BEEN REPORTED ON THIS SPECIFIC LOT PREVIOUSLY. 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 OCTOBER 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 WILL BE 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).

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING POSTERIOR SURGERY, THE VALVE DID NOT WORK AS INTENDED AND LEAKED. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543696 EVA TDC VITRECTOMY PACK VGPC INPUT 23G SURGICAL PACKS AND KITS HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000439415

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown