BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPASS SYSTEM

    MDR report key: 7630389 · Received June 22, 2018

    Report

    Report Number
    3006794299-2018-00204
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    June 7, 2018
    Report Date
    October 26, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ONE OPENED SYSTEM WAS RECEIVED FOR THE REPORTED ISSUE OF RELEASE OF STENT NOT WORKING PROPERLY. THE APPLIER, AND LOADER (IN THE OPENED POSITION AND WITH STENT INSIDE) WERE RETURNED IN THE CONTOUR TRAY WITHIN THE OUTER CARTON. THE APPLIER WAS VISUALLY INSPECTED AND WAS FOUND TO BE CONFORMING. THE LOADER WAS VISUALLY INSPECTED AND WAS FOUND TO BE NON-CONFORMING, WITH STRESS MARKS IN THE CONE OF THE OUTER PUK. THE STENT WAS VISUALLY INSPECTED AND WAS FOUND TO BE CONFORMING. THE APPLIER WAS THEN FUNCTIONALLY TESTED BY PRESSING THE BACK BUTTON TO EXTEND THE GUIDEWIRE, THE APPLIER WAS FOUND TO BE NON-CONFORMING AS THE GUIDEWIRE DID NOT EXTEND FROM THE STOPPER TUBE. THE APPLIER HALVES WERE THEN SEPARATED AND THE GUIDEWIRE WAS VISUALLY INSPECTED AND WAS FOUND TO BE NON-CONFORMING, THE GUIDEWIRE WAS KINKED. THE GUIDEWIRE WAS THEN REMOVED FROM THE STOPPER TUBE TO INSPECT FOR AN ADHESIVE ISSUE AND NO ADHESIVE ISSUE WAS FOUND. THE APPLIER WAS THEN VISUALLY INSPECTED FOR THE PROPER PLACEMENT OF THE FRONT BUTTON SPRING, ADHESIVE BELOW THE PISTON, AND THE RESET SPRING AND WAS FOUND TO BE CONFORMING. THE BUTTON SPRING OUTER DIAMETER AND FREE LENGTH WERE THEN DIMENSIONALLY MEASURED AND WERE 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 SAMPLE IS VISUALLY AND FUNCTIONALLY NON-CONFORMING, THEREFORE THE RELEASE NOT WORKING CORRECTLY WAS CONFIRMED. THE ROOT CAUSE IS USE ERROR DUE TO THAT THE APPLIER WAS MISALIGNED WITHIN THE CONE OF THE LOADER AND WHEN FORCE WAS APPLIED TO THE BACK BUTTON THE GUIDEWIRE BECAME KINKED WITHIN THE APPLIER, THE KINKED APPLIER WOULD THEN NOT CAPTURE OR RELEASE THE STENT CORRECTLY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, LOT HISTORY AND COMPLAINT HISTORY REVIEWS COULD NOT BE CONDUCTED. BASED ON THE PRELIMINARY INVESTIGATION FINDINGS, THERE HAS BEEN NO CHANGE IN CRITICALITY FOR THIS COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT MICRO-STENT IMPLANT DEVICE WOULD NOT TRIGGER AND RELEASE NOT WORKING CORRECTLY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473905 CYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO TRANSCEND MEDICAL INC. NA FG-012018-002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other IOL IMPLANTED: MI60L