BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENISHAW ROBOT LASER

    MDR report key: 18615348 · Received January 30, 2024

    Report

    Report Number
    MW5150932
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 10, 2024
    Report Date
    January 17, 2024
    Manufacturer
    RENISHAW NEURO SOLUTIONS LTD.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE INFORMED ON (B)(6) 2024 THAT DURING AN IMPLANT PROCEDURE, THE REINSHAW ROBOT LASER WAS AT LEAST I CM MEDIAL OUT OF SPECIFICATION ON THE LEFT STAPLE/TRAJECTORY WHICH LED TO AN ABORTED PROCEDURE. THE PROCEDURE TOOK PLACE ON (B)(6) 2024 WITH DR. (B)(6) AT THE (B)(6) MEDICAL CENTER. PLEASE NOTE THIS IS NOT A DEVICE MANUFACTURED BY (B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420369 RENISHAW ROBOT LASER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW RENISHAW NEURO SOLUTIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown