BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE¿

    MDR report key: 2931918 · Received January 28, 2013

    Report

    Report Number
    3005099803-2013-00406
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE DEVICE RETURNED WITH NO VISIBLE DEFECTS. 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 THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE REPORTED EVENT OF NO ENERGY DELIVERED THROUGH THE DEVICE 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 SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE WAS ADVANCED THROUGH THE SCOPE AND INTO THE PATIENT FOR THE FIRST PASS AND THE GOLD PROBE WORKED FINE. REPORTEDLY, THE GOLD PROBE WAS THEN REMOVED FROM THE SCOPE TO WIPE OFF THE TIP. THE GOLD PROBE WAS THEN REINSERTED AND ADVANCED THROUGH THE SCOPE AND BACK INTO THE PATIENT HOWEVER; THE DEVICE FAILED TO CONDUCT ELECTRICAL CURRENT. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN MORE COMPLETE INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE WAS ADVANCED THROUGH THE SCOPE AND INTO THE PATIENT FOR THE FIRST PASS AND THE GOLD PROBE WORKED FINE. REPORTEDLY, THE GOLD PROBE WAS THEN REMOVED FROM THE SCOPE TO WIPE OFF THE TIP. THE GOLD PROBE WAS THEN REINSERTED AND ADVANCED THROUGH THE SCOPE AND BACK INTO THE PATIENT HOWEVER; THE DEVICE FAILED TO CONDUCT ELECTRICAL CURRENT. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN MORE COMPLETE INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37872 GOLD PROBE¿ UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560070 0015454717

    Patients

    Seq Age Sex Outcome Treatment
    1