BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPASS SYSTEM

    MDR report key: 7847755 · Received September 5, 2018

    Report

    Report Number
    3006794299-2018-00279
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 2, 2018
    Report Date
    September 16, 2019
    Manufacturer
    TRANSCEND MEDICAL INC.
    Product Code
    OGO
    PMA / PMN Number
    P150037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION FOR THE REPORTED ISSUE OF HYPHEMA, HYPOTONY, HEMORRHAGE, AND POOR VISION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. 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. BECAUSE A SAMPLE WAS NOT RETURNED AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THERE IS NO REPORT OF DEVICE MALFUNCTION. POSSIBLE ROOT CAUSES ARE THAT POSTOPERATIVE HYPOTONY, HYPHEMA, AND WORSENING IN VISUAL FIELD LOSS ARE ESTABLISHED RISKS ASSOCIATED WITH USE OF THE SYSTEM THAT IS CLEARLY SPECIFIED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTER HAS NOT PROVIDED SUFFICIENT CLINICAL DATA FOR EVALUATION WITH THIS COMPLAINT. THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED. 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. BECAUSE SUFFICIENT CLINICAL DATA WAS NOT RECEIVED, AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    (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 FOLLOWING A MICRO-STENT IMPLANT PROCEDURE, A PATIENT EXPERIENCED HYPOTONY, HYPHEMA, CELLS+2, MILD COMING THROUGH THE DEVICE AND POOLING ON IRIS. SUB CONJ. HEMORRHAGE. THE PATIENT ALSO REPORTED POOR VISION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690144 CYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO TRANSCEND MEDICAL INC. NA FG-042018-002

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other PRED-GATI-BROM GTTS QID WITH TAPER