BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPASS SYSTEM

    MDR report key: 7702421 · Received July 19, 2018

    Report

    Report Number
    3006794299-2018-00236
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    July 5, 2018
    Report Date
    October 4, 2018
    Manufacturer
    TRANSCEND MEDICAL INC.
    Product Code
    OGO
    PMA / PMN Number
    P150037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED COMPANY STENT SYSTEM WAS RECEIVED FOR THE REPORTED ISSUE OF DEVICE DOES NOT DISENGAGE THE COMPANY STENT ONCE IT WAS LOADED. THE LOADER AND APPLIER WERE RETURNED IN THE CONTOUR TRAY OF THE OUTER CARTON, NO STENT WAS RETURNED. THE APPLIER WAS VISUALLY INSPECTED AND WAS FOUND TO BE NON-CONFORMING WITH A BENT STOPPER TUBE. THE LOADER WAS VISUALLY INSPECTED AND WAS FOUND TO BE NON-CONFORMING WITH WHITE STRESS MARKS IN THE CONE OF THE OUTER PUK. THE APPLIER WAS FUNCTIONALLY TESTED AND WAS FOUND TO BE CONFORMING. A LAB INVENTORY STENT WAS THEN LOADED INTO THE RETURNED LOADER, AND THE RETURNED APPLIER AND LOADER AND LAB INVENTORY STENT WERE THEN FUNCTIONALLY TESTED AND WERE FOUND TO BE CONFORMING. THE STENT WAS LOADED AND RELEASED AS INTENDED. THE APPLIER WAS THEN VISUALLY INSPECTED FOR THE PRESENCE AND POSITION OF THE FRONT BUTTON SPRING AND WAS FOUND TO BE CONFORMING. THE BUTTON SPRING WAS THEN DIMENSIONALLY MEASURED FOR OUTER DIAMETER AND FREE LENGTH AND WAS FOUND TO BE CONFORMING. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THERE ARE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. THE RETURNED APPLIER VISUALLY NON-CONFORMING BUT WAS FOUND TO BE CONFORMING FOR ALL FUNCTIONAL TESTING ASSOCIATED WITH THE REPORTED EVENT, THEREFORE A DEVICE DID NOT DISENGAGE THE STENT AS DESCRIBED IN THE COMPLAINT WAS NOT CONFIRMED. HOWEVER SINCE THE ACTUAL STENT WAS NOT RETURNED, A ROOT CAUSE CANNOT BE DETERMINED FOR THE COMPLAINT AS DESCRIBED BY THE CUSTOMER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT DURING A GLAUCOMA STENT IMPLANT SURGERY, THE STENT WOULD NOT DISENGAGE AFTER LOADING. THE SURGERY WAS COMPLETED WITH NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544612 CYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO TRANSCEND MEDICAL INC. NA FG-122017-006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other