BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROVASIVE GOLD PROBE

    MDR report key: 1780500 · Received August 3, 2010

    Report

    Report Number
    3005099803-2010-03258
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN HOWEVER, IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. THE CUSTOMER'S COMPLAINT FOR THE DEVICE FAILING TO CAUTERIZE DURING THE PROCEDURE HAS BEEN CONFIRMED. THE INITIAL VISUAL INSPECTION DURING ANALYSIS REVEALED NO ANOMALIES. HOWEVER, THE DEVICE FAILED ONE OF THE ELECTRICAL TESTS; ONLY ONE OF THE GOLD BANDS RESPONDS, WHEN TESTING USING A MULTIMETER. DISSECTION OF THE BODY CONNECTOR REVEALED ONE OF THE COPPER WIRES PINCHED/SHEARED. THIS MOST LIKELY OCCURRED SOMETIME DURING THE CONNECTOR ASSEMBLY PROCESS DURING MANUFACTURING. FURTHER INVESTIGATION OF THIS ISSUE IS ONGOING. 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

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. HOWEVER, AS THE DEVICE WAS NOT TESTED PRIOR TO PLACING IT DOWN THE SCOPE, IMPROPER GENERATOR SETTINGS MAY HAVE CONTRIBUTED TO THE CAUTERY ISSUE EXPERIENCED BY THE END USER. THEREFORE, OPERATIONAL CONTEXT IS THE MOST PROBABLE CAUSE OF FAILURE. 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. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD POBE DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE DEVICE WAS INSERTED INTO THE PATIENT AND POSITIONED WITHIN THE STOMACH TO TREAT AN ULCER. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO CAUTERIZE THE TISSUE, THE GOLD PROBE FAILED TO DELIVER ELECTRICAL CURRENT. AN ADAPTOR CORD WAS USED IN CONJUNCTION WITH THE GOLD PROBE; IT WAS UNKNOWN WHAT BRAND OF GENERATOR WAS USED. THE GOLD PROBE DEVICE WAS REMOVED FROM THE PATIENT. THE ACCOUNT REPORTED NO VISIBLE DAMAGE TO THE DEVICE; THE GOLD PROBE DEVICE WAS NOT TESTED PRIOR TO INSERTING IT INTO THE PATIENT. A SECOND GOLD PROBE OF THE SAME TYPE WAS USED ALONG WITH THE SAME ADAPTOR CORD AND GENERATOR TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD POBE DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE DEVICE WAS INSERTED INTO THE PATIENT AND POSITIONED WITHIN THE STOMACH TO TREAT AN ULCER. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO CAUTERIZE THE TISSUE, THE GOLD PROBE FAILED TO DELIVER ELECTRICAL CURRENT. AN ADAPTOR CORD WAS USED IN CONJUNCTION WITH THE GOLD PROBE; IT WAS UNKNOWN WHAT BRAND OF GENERATOR WAS USED. THE GOLD PROBE DEVICE WAS REMOVED FROM THE PATIENT. THE ACCOUNT REPORTED NO VISIBLE DAMAGE TO THE DEVICE; THE GOLD PROBE DEVICE WAS NOT TESTED PRIOR TO INSERTING IT INTO THE PATIENT. A SECOND GOLD PROBE OF THE SAME TYPE WAS USED ALONG WITH THE SAME ADAPTOR CORD AND GENERATOR TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MIAMI M00560070 0012925044

    Patients

    Seq Age Sex Outcome Treatment
    1