BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6927639 · Received October 7, 2017

    Report

    Report Number
    1226348-2017-10734
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    September 10, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSOR WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOR THE COMPONENT FOUND THT THE SENSOR MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. A REVIEW OF FINISHED GOOD RECORDS WAS NOT POSSIBLE, AS THE LOT NUMBER WAS NOT PROVIDED. EVALUATION OF THE RETURNED SENSOR FOUND NO DAMAGE TO THE SENSOR OR CONNECTOR. THERE WERE SEVERE INDENTATIONS IN THE CATHETER MATERIAL 8.5 CM FROM THE TIP. THE DEVICE PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    THE SENSOR WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOR THE COMPONENT FOUND THT THE SENSOR MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. A REVIEW OF FINISHED GOOD RECORDS WAS NOT POSSIBLE, AS THE LOT NUMBER WAS NOT PROVIDED. EVALUATION OF THE RETURNED SENSOR FOUND NO DAMAGE TO THE SENSOR OR CONNECTOR. THERE WERE SEVERE INDENTATIONS IN THE CATHETER MATERIAL 8.5 CM FROM THE TIP. THE DEVICE PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K)# OF SIMILAR PRODUCT CODE OF 826631: K914479. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, A MICROSENSOR, AFTER IMPLANTATION, GAVE INACCURATE READINGS. MICROSENSOR WAS REMOVED AND ANOTHER IMPLANTED TO COMPLETE THE PROCEDURE. NO DELAYS OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707055 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention