BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 2010567 · Received March 8, 2011

    Report

    Report Number
    3005099803-2011-00621
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF THE INJECTION GOLD PROBE FAILING TO PRODUCE HEAT WAS NOT ABLE TO BE CONFIRMED. THE PROBE PASSED ALL ELECTRICAL TESTING. VISUAL INSPECTION OF THE RETURNED INJECTION GOLD PROBE FOUND A KINK IN THE MIDDLE OF THE CATHETER, BUT THE NEEDLE WAS ABLE TO EXTEND AND RETRACT WITHOUT DIFFICULTY. THE MOST PROBABLE ROOT CAUSE OF THE KINK IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE (B)(4). THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. 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 AN INJECTION GOLD PROBE DEVICE WAS USED DURING A PROCEDURE. THE TYPE OF PROCEDURE, AND ANATOMY LOCATION, IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INJECTION GOLD PROBE DEVICE FAILED TO PRODUCE HEAT. THE PROBLEM OCCURRED INSIDE THE PATIENT. THE CASE WAS ABLE TO BE COMPLETED WITH ANOTHER INJECTION GOLD PROBE DEVICE AND THE SAME GENERATOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED DURING A PROCEDURE. THE TYPE OF PROCEDURE, AND ANATOMY LOCATION, IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INJECTION GOLD PROBE DEVICE FAILED TO PRODUCE HEAT. THE PROBLEM OCCURRED INSIDE THE PATIENT. THE CASE WAS ABLE TO BE COMPLETED WITH ANOTHER INJECTION GOLD PROBE DEVICE AND THE SAME GENERATOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MIAMI M00560150 13535000

    Patients

    Seq Age Sex Outcome Treatment
    1