BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAB360 TRABECULOTOMY SYSTEM

    MDR report key: 6433193 · Received March 24, 2017

    Report

    Report Number
    3010363671-2017-00003
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    SIGHT SCIENCES, INC.
    Product Code
    HMZ
    UDI-DI
    00858027006112
    PMA / PMN Number
    K132494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE INITIAL REPORT CONTAINED AN ERROR WHERE THE 510(K) NUMBER PROVIDED WAS INCORRECT. THIS DEVICE INVOLVED IN THIS EVENT IS 510(K) EXEMPT AND THERE IS NO ASSOCIATED 510(K) NUMBER.

    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 803. MFR REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED SEVERING THE TIP OF THE TRABECULOTOME WHILE PERFORMING A TRABECULOTOMY. THE ENTIRE DEVICE WAS REMOVED FROM THE EYE WITHOUT INCIDENT. A NEW DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE CASE. THE EVENT DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216135 TRAB360 TRABECULOTOMY SYSTEM TRABECULOTOME HMZ SIGHT SCIENCES, INC. 03706 00858027006112

    Patients

    Seq Age Sex Outcome Treatment
    1