BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE?

    MDR report key: 3120685 · Received May 20, 2013

    Report

    Report Number
    3005099803-2013-03633
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES. AN ELECTRICAL EVALUATION WAS PERFORMED, WHICH INCLUDED LOAD AND ISOLATION OF ELECTRODE TESTS; THE DEVICE PASSED BOTH TESTS. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (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 DEVICE WAS USED DURING A POLYP REMOVAL PROCEDURE PERFORMED IN THE COLON ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE WOULD NOT WORK; IT WOULD NOT TURN ON. NO DAMAGE WAS NOTED TO THE PACKAGING. ANOTHER GOLD PROBE DEVICE WAS USED TO COMPLETE THE PROCEDURE USING THE SAME EQUIPMENT. 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 PROBE DEVICE WAS USED DURING A POLYP REMOVAL PROCEDURE PERFORMED IN THE COLON ON (B)(6), 2013.ACCORDING TO THE COMPLAINANT, THE GOLD PROBE WOULD NOT WORK; IT WOULD NOT TURN ON. NO DAMAGE WAS NOTED TO THE PACKAGING. ANOTHER GOLD PROBE DEVICE WAS USED TO COMPLETE THE PROCEDURE USING THE SAME EQUIPMENT.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
    221451 GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560071 15682909

    Patients

    Seq Age Sex Outcome Treatment
    1