BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM

    MDR report key: 9555681 · Received January 6, 2020

    Report

    Report Number
    2032546-2020-00003
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 6, 2020
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    UDI-DI
    00853704002203
    PMA / PMN Number
    P170043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS NOT AVAILABLE; THEREFORE, PRODUCT TESTING ON THE ACTUAL DEVICE COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. AS PART OF THE DEVICE HISTORY RECORDS REVIEW, THE STERILIZATION RECORDS FOR THIS LOT WERE REVIEWED AND THE DEVICE WAS STERILIZED AND RELEASED ACCORDING TO THE PRODUCT'S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY REVIEW WAS COMPLETED. THE ELECTRONIC COMPLAINT SYSTEM WAS SEARCHED FOR LOT 123779. THERE WERE NO SIMILAR ISSUES REPORTED FOR THIS LOT #. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. ENDOPHTHALMITIS AND DECREASED/IMPAIRED VISION ARE IDENTIFIED IN THE LABELING AS KNOWN INHERENT RISKS OF CATARACT/TRABECULAR MICRO-BYPASS STENT PROCEDURE. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. ENDOPHTHALMITIS IS AN INHERENT RISK OF ANY OCULAR SURGERY AND THE ETIOLOGY OF THE INFECTION IN THIS CASE IS NOT KNOWN. BASED ON THE RESULTS OF THE INVESTIGATION, NO QUALITY PRODUCT DEFICIENCY WAS IDENTIFIED. AS REPORTED- THE FACILITY'S STERILIZER WAS NOT WORKING AT THE TIME, AND THE FACILITY WAS "FLASHING ALL REUSABLE SURGICAL INSTRUMENTS." BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION FINDINGS, THE FACILITY¿S LACK OF A FUNCTIONING STERILIZER (AT THAT TIME) LIKELY CONTRIBUTED TO THE REPORTED EVENT. MFR# REFERENCE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING UNEVENTFUL RIGHT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED ON POST-OP DAY ONE (1) WITH ENDOPHTHALMITIS ASSOCIATED WITH DECREASED VISUAL ACUITY. PER REPORT, THE PATIENT WAS REFERRED TO A SPECIALIST. THE REPORT NOTED THAT THE FACILITY'S STERILIZER WAS NOT WORKING AT THE TIME, AND THE FACILITY WAS "FLASHING ALL REUSABLE SURGICAL INSTRUMENTS." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14280 ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION G2-M-IS 123779 00853704002203

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention