BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 5999636 · Received October 5, 2016

    Report

    Report Number
    1226348-2016-10701
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 6, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION -- DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, LOT #/MODEL #, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. THE DEVICE WAS RETURNED AND EVALUATED. A REVIEW OF MANUFACTURING RECORDS FOUND THAT THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE INTERNAL CATHETER WIRES WERE BROKEN INSIDE THE CATHETER. THERE WAS A CUT IN THE CATHETER MATERIAL 3 CM FROM THE SENSOR CASE. THE CATHETER MATERIAL WAS MASHED 4 CM AND SCRATCHED 5 CM FROM THE TIP OF THE CATHETER. THE CATHETER WAS SEVERELY MASHED/CREASED 25 CM FROM THE CONNECTOR. THE CATHETER MATERIAL WAS MASHED/STRETCHED UNDER CONNECTOR STRAIN RELIEF AND THE CODMAN LABEL WAS LIFTING ON THE CONNECTOR. DUE TO THE CONDITION OF THE DEVICE AS IT WAS RECEIVED, NO FURTHER FUNCTIONAL TESTING WAS POSSIBLE. BASED ON THEIR EVALUATION, THE SUPPLIER WAS ABLE TO CONFIRM THE REPORTED COMPLAINT AND DETERMINED THE CAUSE OF FAILURE TO BE MISHANDLING OF THE CATHETER. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD NOT BE MADE AVAILABLE FOR EVALUATION. HOWEVER, THE DEVICE HAS SINCE BEEN RETURNED. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE MADE AVAILABLE FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE UNSUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION WAS PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    CODMAN MICROSENSOR FAILURE AFTER CT WITH CERETOM PORTABLE CT SCANNER AT THE NEURO ICU DEPARTMENT. MESSAGE IN MONITOR DISPLAY "CENO TRANSDUCER DETECTED; EXPECT MORE INFO FROM CUSTOMER. PER REP: DID THIS EVENT OCCUR INTRA-OPERATIVELY? NO. DID THE REPORTED EVENT CAUSE ANY DELAYS IN THE PROCEDURE OR SURGERY OVER 30 MINUTES? NO. WHAT ACTION WAS TAKEN TO RESOLVE THE ISSUE? THE CODMAN MICROSENSOR WAS REMOVED. THE PATIENT ALSO HAD A EVD THAT COULD BE USED FOR ICP-MEASUREMENT. WERE THERE ANY ADVERSE CONSEQUENCES TO THE PATIENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650767 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1