BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM

    MDR report key: 10960420 · Received December 7, 2020

    Report

    Report Number
    2032546-2020-00105
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 16, 2020
    Report Date
    March 4, 2021
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    UDI-DI
    00853704002319
    PMA / PMN Number
    P170043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3. EVALUATION OF THE RETURNED DEVICE WAS COMPLETED. THE X-RAY EVALUATION REVEALED THAT THE CAM ASSEMBLY HAD BEEN ACTIVATED TWICE AND NO STENTS WERE FOUND. THE TRIGGER BUTTON MOTION WAS FUNCTIONING AS INTENDED. THE INJECTOR¿S SPLAYED TROCAR WAS FOUND BROKEN AT THE PROXIMAL ROOT OF THE SPLAY. THE BROKEN TIP OF THE TROCAR WAS NOT RETURNED. THIS FINDING LIKELY OCCURRED DURING THE SURGICAL PROCEDURE, AS DESCRIBED IN THE CUSTOMER¿S REPORTED ISSUE. NO DAMAGE WAS OBSERVED ON THE INSERTION TUBE V-SLOT. HOWEVER, THE TROCAR WAS BENT UP, WHICH SUGGESTED THAT IT WAS HEAVILY BIASED OUTSIDE OF THE V-SLOT DURING THE EVENT. IT IS HIGHLY UNLIKELY THAT THE DEVICE WAS SENT OUT IN THIS CONDITION AS THE FRONTAL COMPONENTS UNDERGO CRITICAL DIMENSION INSPECTION AFTER INJECTOR ASSEMBLY PER MANUFACTURING PROCEDURE. IF ANY OF THE FRONTAL COMPONENTS WERE BENT, THE DEVICE SHOULD FAIL INSPECTION AND THE UNIT SHOULD GET REJECTED. FURTHERMORE, ALL DEVICES UNDERGO VISUAL INSPECTION VIA X-RAY. IF ANY OF THE FRONTAL COMPONENTS WERE BENT DURING X-RAY, THE UNIT SHOULD GET REJECTED. THERE WERE NO NON-CONFORMANCES FOUND TO BE RELATED TO REPORTED EVENT. A REVIEW OF X-RAY IMAGES FOR LOT 101732, REVEALED THAT ACCEPTED DEVICE INJECTORS CONTAINED SPLAYED TROCARS THAT HAVE MET THE REQUIRED SPECIFICATIONS. IT IS HIGHLY UNLIKELY THAT THE SPLAYED TROCAR WAS SHIPPED OUT BENT OR BROKEN AS IT UNDERGOES CRITICAL DIMENSION INSPECTION AFTER INJECTOR ASSEMBLY. BASED ON THESE FINDINGS, THE ROOT CAUSE OF THE CUSTOMER¿S REPORTED ISSUE WAS NOT CONCLUSIVELY IDENTIFIED; HOWEVER, THE MOST LIKELY CAUSE IS A HEAVILY BIASED TROCAR DURING THE FIRING OF THE FIRST OR SECOND STENT. A COMPLAINT HISTORY REVIEW WAS COMPLETED. THE ELECTRONIC COMPLAINT SYSTEM WAS SEARCHED FOR THE SPECIFIED LOT#. THERE WERE NO SIMILAR ISSUES REPORTED FOR THIS LOT #. MFR# REFERENCE:30226

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURN TO GLAUKOS FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT WAS PERFORMED AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE LABELING INCLUDING THE RISK ANALYSIS WAS COMPLETED. THE REPORTED ISSUE WAS IDENTIFIED TO BE AN ANTICIPATED HAZARD. THE RESIDUAL RISK FOR EACH POTENTIAL HARM WAS FOUND TO BE WITHIN THE INSIGNIFICANT RISK REGION. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A RIGHT EYE CATARACT PROCEDURE, THE TROCAR OF A TRABECULAR MICRO BYPASS STENT SYSTEM ¿CAME OFF¿ INTRAOPERATIVELY. THE REMNANT WAS SUCCESSFULLY REMOVED INTRAOPERATIVELY, AND THERE WAS NO PATIENT INJURY. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422708 ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION G2-W-US 101732 00853704002319

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR