BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBRE OPTIC CATHETER CABLE

    MDR report key: 4733261 · Received April 24, 2015

    Report

    Report Number
    8010219-2015-00021
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Report Date
    April 2, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    GWM
    PMA / PMN Number
    K121573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 1/28/2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: ALTHOUGH THE CAMCABL CABLE PASSED FUNCTIONAL INSPECTION WITHIN SPECIFICATIONS, IT FAILED VISUAL INSPECTION DUE TO TEFLON SECTION SURROUNDING THE PIN ON THE TEMPERATURE CONNECTOR WAS PROTRUDING FAR PAST THE PIN. THIS FAULT CAN BE CONCLUDED DUE TO PHYSICAL DAMAGE TO THE CABLE. A REVIEW OF COMPLAINTS HISTORY REVEALED NO TREND IDENTIFIED. CONCLUSION: THE CUSTOMER COMPLAINT INCIDENT ¿PIN IS DAMAGED / BENT¿ WAS VERIFIED AND DUPLICATED. THE ROOT CAUSE DETERMINED TO BE THE TEFLON SECTION SURROUNDING THE PIN ON THE TEMPERATURE CONNECTOR PROTRUDING FAR PAST THE PIN, CONCLUDED AS PHYSICAL DAMAGE.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/23/2015. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: DHR REVIEW WAS COMPLETED FOR CAMCABL CABLE SERIAL NUMBER (B)(4), WORK ORDER 232079, LOT NUMBER TL-319943 MANUFACTURED IN TULLAMORE, IRELAND, TO IDENTIFY ANY RECORDED ANOMALIES THAT COULD BE ASSOCIATED TO THE COMPLAINT INCIDENT. DATE OF MANUFACTURE: OCT-2014. THE DHR REVIEW HAS BEEN DEEMED SATISFACTORY. A MINIMUM OF 12 MONTH REVIEW OF CAMCABL MONITOR CUSTOMER COMPLAINTS WAS COMPLETED IN TRACKWISE® USING THE FOLLOWING KEY WORDS ¿DEFECTIVE CABLE¿ AND A ROOT CAUSE ¿PRODUCT NOT RETURNED¿ IN SEARCH CRITERIA. THE KEY WORD SEARCH REVIEW OF THE COMPLAINTS CONTAINED ALL AND/OR PART OF THE KEY WORDS TO COMPLETE A COMPREHENSIVE TREND REVIEW. THE ANALYSIS OF THE COMPLAINT INVESTIGATIONS AND ROOT CAUSE REPORTS HAS CONCLUDED THIS IS THE 2ND IDENTIFIED COMPLAINT FOR THE REPORTED FAILURE ASSOCIATED WITH THE CAMCABL CABLE THAT HAS NOT BEEN RETURNED FOR EVALUATION. NO TREND HAS BEEN IDENTIFIED. NO REVIEW OF NON-CONFORMANCE REPORTS (NCRS) IS DEEMED NECESSARY AS THE ROOT CAUSE OF THE COMPLAINT INCIDENT WAS NOT DETERMINED. CONCLUSION: SINCE THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS INVESTIGATION NO ROOT CAUSE CAN BE ESTABLISHED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE PIN WAS DAMAGED/BENT. OUT OF BOX FAILURE. THERE WAS NO PT CONTACT NO PT PREPPED FOR SURGERY, NO PT INJURY AND NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273435 FIBRE OPTIC CATHETER CABLE ICP MONITORING GWM INTEGRA NEUROSCIENCES, LTD. TL-319943

    Patients

    Seq Age Sex Outcome Treatment
    1