BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE¿

    MDR report key: 2780300 · Received October 10, 2012

    Report

    Report Number
    3005099803-2012-04747
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILED TO DELIVER ENERGY. 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 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. AFTER PERFORMING THE PRODUCT ANALYSIS, THE DEVICE IS WITHIN SPECIFICATIONS. PRODUCT ANALYSIS COULD NOT CONFIRM THE DEFICIENCY REPORTED BY THE CUSTOMER. 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 TO BE USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITHIN THE DUODENUM PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FAILED TO CONDUCT ELECTRICAL CURRENT. REPORTEDLY, THERE WERE NO VISIBLE SIGNS OF ENERGY COMING FROM THE DEVICE. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN TESTED IN SALINE, BUT IT STILL FAILED TO DELIVER ENERGY. THE POWER WAS SWITCHED AND THE PROBE WAS RE-TESTED WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED USING A SECOND GOLD PROBE AND THE ORIGINAL GENERATOR WITHOUT ANY FURTHER ISSUES. NO PATIENT COMPLICATIONS RESULTED FROM 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 WAS TO BE USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITHIN THE DUODENUM PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FAILED TO CONDUCT ELECTRICAL CURRENT. REPORTEDLY, THERE WERE NO VISIBLE SIGNS OF ENERGY COMING FROM THE DEVICE. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN TESTED IN SALINE, BUT IT STILL FAILED TO DELIVER ENERGY. THE POWER WAS SWITCHED AND THE PROBE WAS RE-TESTED WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED USING A SECOND GOLD PROBE AND THE ORIGINAL GENERATOR WITHOUT ANY FURTHER ISSUES. NO PATIENT COMPLICATIONS RESULTED FROM 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 GOLD PROBE¿ UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560071 15333154

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR