BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVA TDC VITRECTOMY PACK VGPC INPUT 25G

    MDR report key: 8241045 · Received January 11, 2019

    Report

    Report Number
    1222074-2019-00007
    Event Type
    Injury
    Date Received
    January 11, 2019
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
    Product Code
    QDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WILL START AS SOON AS PRODUCT IS RECEIVED. FOLLOW UP (B)(6) 2019: INVESTIGATION COULD NOT BE STARTED AS PRODUCT WAS NOT RECEIVED BY DORC YET. CUSTOMER INDICATED THAT THE AFFECTED PRODUCT WAS SENT TO D.O.R.C. ON FRIDAY (B)(6) 2019. INVESTIGATION WILL START AS SOON AS PRODUCT IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE AFFECTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION, DESPITE SEVERAL ATTEMPTS TO LOCATE IT WITHIN THE LOGISTIC CHAIN. SUBSEQUENT TO THE INITIAL REPORT, DORC HAS BEEN WORKING TO CLARIFY THE CIRCUMSTANCES OF THE ISSUE WITH THE CUSTOMER. DORC WAS INFORMED BY THE DORC AREA SALES MANAGER THAT AFTER CONSULTING THE SURGEON, IT WAS THEIR OPINION THAT THE LACK OF INFUSION WAS NOT CAUSED BY THE ALLEGED DEFAULT OF THE PACK. A REVIEW OF THE SETTINGS UTILISED FOR SURGERY INDICTED THAT THE INFUSION LEVEL IN THE SURGICAL STEP "VITRECTOMY PERIPHERIQUE" WAS POTENTIALLY TOO LOW IN THE CASES CONCERNED AND MAY HAVE CONTRIBUTED TO THE HYPOTONY. THE SURGEON HAS NOW ADJUSTED THE SURGICAL PARAMETERS AFTER SEVERAL SURGERIES NO OTHER ISSUES OCCURRED. THE EVA SURGICAL SYSTEM IS REQUIRED TO OFFER A FULL RANGE OF PRESSURE SETTINGS FOR SURGEONS, INCLUDING LOWER PRESSURE SETTINGS FOR CLINICAL SITUATIONS WHERE THIS APPROPRIATE. AS NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED, NO CORRECTIVE ACTION IS IDENTIFIED.

    Description of Event or Problem · 0

    HYPOTONIA DURING THE VITRECTOMIE.

    Description of Event or Problem · 0

    HYPOTONIA DURING THE VITRECTOMIE.

    Additional Manufacturer Narrative · 1

    TEXT RECEIVED FROM CUSTOMER: HYPOTONIA DURING THE VITRECTOMIE. INVESTIGATION WILL START AS SOON AS PRODUCT IS RECEIVED.

    Description of Event or Problem · 1

    HYPOTONIA DURING THE VITRECTOMIE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32824 EVA TDC VITRECTOMY PACK VGPC INPUT 25G OPHTHALMIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE QDY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2000395330

    Patients

    Seq Age Sex Outcome Treatment
    1