BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA VITRECTOMY PACK GRAVITY INPUT 25G

    MDR report key: 16642459 · Received March 30, 2023

    Report

    Report Number
    1222074-2023-00032
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    February 17, 2023
    Report Date
    May 25, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
    Product Code
    QDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CAUSE INVESTIGATION: UNFORTUNATELY, NONE OF THE DISPOSABLE PRODUCTS FORM THE PACK WERE RETURNED TO DORC FOR INVESTIGATION. UNFORTUNATELY, WITHOUT ANY PHYSICAL EXAMINATION AND/OR TESTING, THE REPORTED FAILURE COULD NOT BE CONFIRMED AND ITS CAUSE COULD NOT BE DETERMINED. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS AND A DATABASE SEARCH SHOWED THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ON THIS SPECIFIC LOT PRIOR TO THIS CASE OR SINCE. RESULTS OF ASSESSMENT: THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS.

    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. AS INVESTIGATIONS ON THE ACTUAL PRODUCT OR REPRESENTATIVE SAMPLE OF A BATCH MAY ALTER THE DEVICE, WE REQUEST TO INFORM US WITHIN 7 DAYS AFTER SUBMISSION OF THIS REPORT, IN CASE THE INVESTIGATIONS THAT ALTER THE DEVICE SHOULD BE HALTED UNTIL APPROVAL OF THE NCA, AS PER ARTICLE 89 OF EU-MDR.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING VITRECTOMY PROCEDURE, WATER LEAKED OUT OF THE INSTRUMENT CAUSING THE FORMATION OF AIR BUBBLES THAT ENTERED THE EYE OF THE PATIENT. IRRIGATION WAS INSUFFICIENT. 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 VITRECTOMY PROCEDURE, WATER LEAKED OUT OF THE INSTRUMENT CAUSING THE FORMATION OF AIR BUBBLES THAT ENTERED THE EYE OF THE PATIENT. IRRIGATION WAS INSUFFICIENT. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226392 EVA VITRECTOMY PACK GRAVITY INPUT 25G VITRECTOMY PACK GRAVITY INPUT 25G QDY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2000441076
    667036 EVA VITRECTOMY PACK GRAVITY INPUT 25G VITRECTOMY PACK GRAVITY INPUT 25G QDY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2000441076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown