BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE CORD

    MDR report key: 2792639 · Received October 16, 2012

    Report

    Report Number
    3005099803-2012-04449
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND NO ISSUES. THE BANANA JACK INNER DIAMETER, SHAFT DIAMETER, AND TIP DIAMETER WERE ALL MEASURED, AND ALL WERE FOUND TO BE WITHIN SPECIFICATIONS. AS THE ACCESSORY DEVICE WAS NOT RETURNED, THE ACTIVE CORD COULD NOT BE FUNCTIONALLY EVALUATED WITH RESPECT TO FAILURE TO CONNECT TO THE ACCESSORY DEVICE. THE DEVICE PHYSICAL ANALYSIS AND MEASUREMENTS CONFIRM THAT THE DEVICE MET SPECIFICATIONS. THE LOT NUMBER WAS NOT REPORTED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS IS A REUSABLE DEVICE; THEREFORE, THERE IS NO EXPIRATION DATE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE IS UNKNOWN. (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT AN ACTIVE CORD WAS USED DURING PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ACTIVE CORD WOULD NOT STAY CONNECTED TO THE SNARE. IT WAS STATED THAT THE CONNECTION WAS LOOSE. THERE WAS NO REPORTED MALFUNCTION WITH THE SNARE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS ACTIVE CORD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT AN ACTIVE CORD WAS USED DURING PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ACTIVE CORD WOULD NOT STAY CONNECTED TO THE SNARE. IT WAS STATED THAT THE CONNECTION WAS LOOSE. THERE WAS NO REPORTED MALFUNCTION WITH THE SNARE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS ACTIVE CORD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE CORD UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00561270

    Patients

    Seq Age Sex Outcome Treatment
    1