BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE?

    MDR report key: 3840527 · Received May 30, 2014

    Report

    Report Number
    3005099803-2014-02070
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4) FOR THE REPORTED EVENT OF 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 A GOLD PROBE¿ WAS USED DURING AN ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE GOLD PROBE FAILED TO CAUTERIZE. ADDITIONALLY, THE DEVICE WAS CONNECTED TO AN ADAPTER CABLE AND DESPITE AN INCREASE IN POWER SETTING NO CAUTERY WAS PRODUCED. THE PROCEDURE WAS COMPLETED WITH A SECOND GOLD PROBE USING THE SAME GENERATOR AND SETTINGS. NO VISIBLE ISSUE TO 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318804 GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560100 16477153

    Patients

    Seq Age Sex Outcome Treatment
    1