BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE?

    MDR report key: 3961702 · Received July 28, 2014

    Report

    Report Number
    3005099803-2014-02581
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT¿S EXACT DATE OF BIRTH IS UNKNOWN, BUT IT WAS REPORTED THAT THE PATIENT WAS BORN IN (B)(6). (B)(4) FOR THE REPORTED EVENT OF THE TIP DETACHING. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED IN THE STOMACH DURING A HEMOSTASIS TREATMENT PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE TIP OF THE INJECTION GOLD PROBE DETACHED BUT WAS HANGING BY THE WIRES. THE PHYSICIAN TRIED SHIFTING THE CATHETER TO CONNECT WITH DISTAL TIP AND REMOVED IT FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND INJECTION GOLD PROBE DEVICE. NO VISIBLE ISSUE WITH THE COMPLAINT DEVICE OR THE PACKAGING WAS REPORTED. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439627 INJECTION GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560150 16275482

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR