BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE?

    MDR report key: 3192275 · Received June 27, 2013

    Report

    Report Number
    3005099803-2013-05116
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES. A FUNCTIONAL EVALUATION WAS PERFORMED AND THE NEEDLE EXTENDED AND RETRACTED NORMALLY, AFTER ACTUATION OF THE HANDLE. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, THE PATIENT WAS REPORTED TO BE MIDDLE AGED. (B)(4) FOR THE REPORTED EVENT: PROBE FAILS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD POBE DEVICE WAS USED DURING AN ENDOSCOPY PROCEDURE PERFORMED TO TREAT ULCER SITES IN THE LOWER ESOPHAGUS AND UPPER STOMACH ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INJECTION GOLD PROBE DEVICE WOULD NOT CAUTERIZE. NO ISSUES WERE NOTED WITH THE NEEDLE, AND NO VISIBLE DAMAGE TO THE DEVICE WAS NOTED. THE DEVICE HAD BEEN TESTED BEFORE GOING INTO THE PATIENT AND WORKED WITHOUT ANY PROBLEMS. THE DEVICE WAS TRIED ON TWO DIFFERENT SETS OF EQUIPMENT, AND STILL WOULD NOT WORK. THEREFORE, A NEW GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE. 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 OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED DURING AN ENDOSCOPY PROCEDURE PERFORMED TO TREAT ULCER SITES IN THE LOWER ESOPHAGUS AND UPPER STOMACH ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INJECTION GOLD PROBE DEVICE WOULD NOT CAUTERIZE. NO ISSUES WERE NOTED WITH THE NEEDLE, AND NO VISIBLE DAMAGE TO THE DEVICE WAS NOTED. THE DEVICE HAD BEEN TESTED BEFORE GOING INTO THE PATIENT AND WORKED WITHOUT ANY PROBLEMS. THE DEVICE WAS TRIED ON TWO DIFFERENT SETS OF EQUIPMENT, AND STILL WOULD NOT WORK. THEREFORE, A NEW GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE. 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 OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293553 INJECTION GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560150 15829168

    Patients

    Seq Age Sex Outcome Treatment
    1