BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTAS

    MDR report key: 3472081 · Received October 30, 2013

    Report

    Report Number
    3006515340-2013-00001
    Event Type
    Other
    Date Received
    October 30, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 29, 2013
    Manufacturer
    RESTORATION ROBOTICS
    Product Code
    ONA
    PMA / PMN Number
    K123548
    Removal / Correction Number
    3006515340-10/17/13-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL NUMBERS: (B)(4). DISCOLORATION DUE TO INSUFFICIENT CLEANING OF STAINLESS STEEL PINS DURING PASSIVATION PROCESS. THERE HAVE BEEN NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. USERS NOTIFICATION INITIATED 8 OCT 2013. CORRECTION 3006515340-10/17/13-001C, REPORTED TO (B)(4) FIELD OFFICE (B)(4) 2013.

    Description of Event or Problem · 1

    DISCOLORATION OBSERVED ON PINS USED IN DISPOSABLE SKIN TENSIONER. TO DATE NO SERIOUS INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556283 ARTAS ARTAS SYSTEM ONA RESTORATION ROBOTICS FP-45616 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA