BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS PLUS ELECTRONIC TOOL KIT

    MDR report key: 10218397 · Received July 1, 2020

    Report

    Report Number
    1226348-2020-00324
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 2, 2020
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7, H2, H3, H6, H10 UNIQUE DEVICE IDENTIFICATION (UDI):(B)(4). THE CERTAS TOOL KIT WAS NOT RETURNED THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT AFTER THE PROCEDURE THE SETTING OF THE CERTAS VALVE COULD NOT BE CHANGED BY THE ETK (ELECTRONIC TOOL KIT). THERE WAS A SLIGHT GAP BETWEEN THE DISPLAY AND THE VALVE ITSELF. THEREFORE, IT WAS CHANGED TO ANOTHER ONE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682012 CERTAS PLUS ELECTRONIC TOOL KIT CERTAS PLUS JXG RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1