BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE?

    MDR report key: 3870420 · Received June 12, 2014

    Report

    Report Number
    3005099803-2014-02263
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. REPORTED EVENT OF INJECTION GOLD PROBE FAILED TO CAUTERIZE. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INJECTION GOLD PROBE FAILED TO CAUTERIZE. THE DEVICE WAS DIRECTLY CONNECTED TO THE GENERATOR AND HAD BEEN TESTED PRIOR TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND INJECTION GOLD PROBE USING THE SAME GENERATOR AND SETTINGS. NO VISIBLE ISSUE WITH THE COMPLAINT DEVICE OR THE PACKAGING WAS REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348196 INJECTION GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560150

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR