BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 7039948 · Received November 16, 2017

    Report

    Report Number
    1226348-2017-10852
    Event Type
    Injury
    Date Received
    November 16, 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

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

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF COMPONENT LEVEL QUALITY RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATION PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THE INTERNAL WIRES WERE BROKEN INSIDE THE CATHETER. THE CATHETER MATERIAL WAS BENT AND KINKED AT THE CONNECTOR. INDENTATIONS IN THE CATHETER MATERIAL DUE TO TIGHT SUTURES WERE FOUND. DUE TO THE CONDITION OF THE DEVICE AS IT WAS RECEIVED, NO FUNCTIONAL TESTING WAS POSSIBLE. WE WERE UNABLE TO CONFIRM THE INITIAL ISSUE REPORTED BY THE CUSTOMER DUE TO THE CONDITION OF THE DEVICE. THE CONDITION OF THE SENSOR WAS DETERMINED TO BE USE RELATED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, A MICROSENSOR MALFUNCTIONED 6 DAYS AFTER BEING INSERTED INTO PATIENT. THE ICU STAFF ROLLED THE PATIENT, THEN NOTICED A MESSAGE ON THE ICP MONITOR READING THAT NO TRANSDUCER WAS DETECTED. THE MICROSENSOR WAS REMOVED. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM. PER AFFILIATE: "IT IS UNKNOWN IF THE MICROSENSOR WAS REPLACED OR NOT. THE PRODUCT SPECIALIST IS UNABLE TO PROVIDE FURTHER INFORMATION. IN ADDITION, LOT NUMBER CANNOT BE CONFIRMED AS WELL AS THE CUSTOMER HAD DISPOSED AT THE TIME OF INSERTION. THE REMOVAL PROCEDURE HAPPENED SEVERAL DAYS LATER IN ICU. THE SURGEON ALSO DID NOT RELAY A DAY OR TIME OF SURGERY. NO FURTHER INFORMATION WILL BE FORTHCOMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815983 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention