BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE?

    MDR report key: 3192374 · Received June 27, 2013

    Report

    Report Number
    3005099803-2013-05272
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: PROBE FAILS TO DELIVER ENERGY. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 A GOLD PROBE DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED IN THE STOMACH ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE DEVICE WOULD NOT HEAT UP. NO DAMAGE WAS NOTED TO THE DEVICE, OR PACKAGING. A SECOND GOLD PROBE DEVICE WAS USED WITH THE SAME GENERATOR 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294114 GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560070 15925397

    Patients

    Seq Age Sex Outcome Treatment
    1