BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE¿

    MDR report key: 2942034 · Received February 4, 2013

    Report

    Report Number
    3005099803-2013-00588
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATIONS. FUNCTIONALLY, THE UNIT UNDERWENT ISOLATION OF ELECTRODES TEST AND LOAD TEST AND FOUND THE DEVICE TO MEET SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN HOWEVER; IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS TO BE USED FOR A PROCEDURE, PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER THE GOLD PROBE WAS ADVANCED THROUGH THE SCOPE AND INTO THE PATIENT; THE DEVICE FAILED TO CONDUCT ELECTRICAL CURRENT. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE PROCEDURE WAS SATISFACTORILY COMPLETED USING ANOTHER GOLD PROBE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS TO BE USED FOR A PROCEDURE, PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER THE GOLD PROBE WAS ADVANCED THROUGH THE SCOPE AND INTO THE PATIENT; THE DEVICE FAILED TO CONDUCT ELECTRICAL CURRENT. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE PROCEDURE WAS SATISFACTORILY COMPLETED USING ANOTHER GOLD PROBE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45932 GOLD PROBE¿ UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00560070

    Patients

    Seq Age Sex Outcome Treatment
    1