BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI SURGICAL SYSTEM

    MDR report key: 8254038 · Received January 16, 2019

    Report

    Report Number
    3010363671-2019-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 16, 2019
    Manufacturer
    SIGHT SCIENCES, INC.
    Product Code
    MRH
    UDI-DI
    00858027006310
    PMA / PMN Number
    K173332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO SIGHT SCIENCES, INC. HAS BEEN SUBMITTED. THE COMPANY IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. MFR REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE SURGEON ADVANCED THE MICROCATHETER OF THE OMNI SURGICAL SYSTEM INTO SCHLEMM'S CANAL. AS HE BEGAN TO RETRACT THE MICROCATHETER, HE OBSERVED THAT IS WAS DETACHED FROM CANNULA AND REMAINED IN THE CANAL. HE GRASPED THE DETACHED PORTION WITH FORCEPS AND COMPLETED THE GONIOTOMY SUPERIORLY. HE THEN USED THE FORCEPS TO THREAD THE MICROCATHETER INTO THE OTHER DIRECTION OF SCHLEMM'S CANAL AND CREATED A GONIOTOMY INFERIORLY. HE THEN REMOVED THE MICROCATHETER FROM THE EYE WITH THE FORCEPS. THERE WERE NO INTRAOPERATIVE OR POST-OPERATIVE COMPLICATIONS ASSOCIATED WITH THIS PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47874 OMNI SURGICAL SYSTEM VISCOELASTIC INJECTOR MRH SIGHT SCIENCES, INC. 05600 1006652 00858027006310

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR