BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE?

    MDR report key: 3203056 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-05561
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, 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 A CATHETER KINK NEAR THE BODY CONNECTOR AND A SECTION OF A GOLD BAND MISSING AT THE TIP. THE UNIT ALSO SHOWED BURN MARKS AT THIS AREA. AN ELECTRICAL EVALUATION WAS PERFORMED, WHICH INCLUDED LOAD AND ISOLATION OF ELECTRODE TESTS; THE DEVICE FAILED THE LOAD TEST. THE GOLD BANDS WERE TESTED USING A MULTIMETER AND THERE WAS CONTINUITY IN THE UNIT UNTIL THE MISSING GOLD SECTION. THE COMPLAINT WAS CONFIRMED SINCE THE UNIT FAILED THE LOAD TEST DUE TO THE MISSING GOLD IN A SECTION OF A GOLD BAND. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT, SINCE PROCEDURAL FACTORS PROBABLY LIMITED THE PERFORMANCE OF THE DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2013 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE ATTEMPTING TO CAUTERIZE A DUODENAL ULCER, THE INJECTION GOLD PROBE WOULD NOT GENERATE ENERGY FOR CAUTERIZATION. IT WAS CONFIRMED THAT THE CUSTOMER DID NOT TEST THE CURRENT PRIOR TO THE PROCEDURE. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THEY USED THE INJECTION COMPONENT OF THE DEVICE INSTEAD TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS NO ISSUE WITH THE GENERATOR OR ANY ACCESSORY DEVICES AND THAT THE CAUTERY ISSUE MAY HAVE BEEN CAUSED BY USER ERROR REGARDING THE WATTAGE SETTINGS. 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 INJECTION GOLD PROBE DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE ATTEMPTING TO CAUTERIZE A DUODENAL ULCER, THE INJECTION GOLD PROBE WOULD NOT GENERATE ENERGY FOR CAUTERIZATION. IT WAS CONFIRMED THAT THE CUSTOMER DID NOT TEST THE CURRENT PRIOR TO THE PROCEDURE. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THEY USED THE INJECTION COMPONENT OF THE DEVICE INSTEAD TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS NO ISSUE WITH THE GENERATOR OR ANY ACCESSORY DEVICES AND THAT THE CAUTERY ISSUE MAY HAVE BEEN CAUSED BY USER ERROR REGARDING THE WATTAGE SETTINGS. 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
    302048 INJECTION GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560160 14703709

    Patients

    Seq Age Sex Outcome Treatment
    1