BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE¿

    MDR report key: 2894776 · Received January 3, 2013

    Report

    Report Number
    3005099803-2012-06406
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN HOWEVER; IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18. (B)(4) FOR THE REPORTED EVENT OF 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 PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE DEVICE WAS TESTED IN SALINE HOWEVER; NO BUBBLES APPEARED AND THERE WAS NO CAUTERY. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE ALONG WITH THE ORIGINAL GENERATOR/EQUIPMENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN GOLD PROBE WAS TO BE USED FOR AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE DEVICE WAS TESTED IN SALINE HOWEVER; NO BUBBLES APPEARED AND THERE WAS NO CAUTERY. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE ALONG WITH THE ORIGINAL GENERATOR/EQUIPMENT. 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
    2644 GOLD PROBE¿ UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560070 15419156

    Patients

    Seq Age Sex Outcome Treatment
    1