BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR)

    MDR report key: 10080094 · Received May 21, 2020

    Report

    Report Number
    1222074-2020-00040
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WITH REGARD TO THIS COMPLAINT, NO ITEM WAS RETURNED FOR INVESTIGATION. THEREFORE, NO INVESTIGATION CAN BE PERFORMED AND NO INVESTIGATION RESULTS COULD BE OBTAINED. IN ADDITION, NO ADDITIONAL INFORMATION WAS RECEIVED TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY SIMILAR EVENTS OR REPEAT ISSUE(S). HENCE, BASED UPON THE AVAILABLE INFORMATION THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN. - ATTACHMENT: [MIR 2020-002413 FINAL REPORT SIGNED 1222074-2020-00040 FOLLOW UP 1.PDF].

    Description of Event or Problem · 0

    DURING A PROCEDURE, A SURGEON NOTICED THAT A PRESSURE INSIDE AN EYE FELT HIGHER THAN IT SHOULD BE. IN THE SAME TIME, A VALUE OF AN IRRIGATION PRESSURE INDICATED ON A SCREEN OF AN EVA UNIT WAS AS EXPECTED (FROM THE SETTINGS). THE SURGERY WAS COMPLETED WITH THE SAME UNIT. PATIENT HARM DID NOT OCCUR.

    Additional Manufacturer Narrative · 1

    LOG FILES OF THE EVA SYSTEM WERE RECEIVED BY D.O.R.C.. REVIEW OF THE LOG FILES DID NOT REVEAL A REASON BEHIND THE REPORTED EVENT. FURTHER INVESTIGATION IS NEEDED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, A SURGEON NOTICED THAT THE PRESSURE INSIDE THE EYE FELT HIGHER THAN THE VALUE PRESENTED ON THE SCREEN (WHEN IN IRRIGATION AND NOT DURING AIR FLUID EXCHANGE). THE SURGERY WAS COMPLETED WITH THE SAME UNIT. PATIENT HARM DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541672 EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR) PHACOEMULSIFICATION/VITRECTOMY SYSTEM HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA

    Patients

    Seq Age Sex Outcome Treatment
    1