BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE¿

    MDR report key: 2850626 · Received November 29, 2012

    Report

    Report Number
    3005099803-2012-05496
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE TIP DETACHING. 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 WAS USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GOLD PROBE WAS USED TO TREAT AN AREA OF THE PATIENT'S DUODENUM. REPORTEDLY, AFTER WITHDRAWAL, THE DEVICE DISTAL TIP SEPARATED WHILE THE PHYSICIAN CLEANED TISSUE FROM IT WITH AN ALCOHOL SWAB. THE PHYSICIAN, SATISFIED WITH THE CASE OUTCOME, ENDED THE PROCEDURE AT THIS POINT. 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) M00560070 15421564

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR