BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 1934003 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05243
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN.ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE IN THE DUODENUM. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE TESTED THE NEEDLE AFTER PRIMING THE DEVICE WITH EPINEPHRINE; THE NEEDLE WOULD NOT RETRACT BACK INTO THE SHEATH. THE PHYSICIAN DECIDED NOT TO TREAT THE GI BLEED, AS IT WAS NO LONGER NECESSARY. 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
    1 INJECTION GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA M00560150

    Patients

    Seq Age Sex Outcome Treatment
    1