BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 2091798 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01708
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NEEDLE BECAME STUCK IN THE EXTENDED POSITION; IT WOULD NOT RETRACT. THE PHYSICIAN HAD ALREADY COMPLETED THE PROCEDURE WITH THIS DEVICE WHEN THE ISSUE OCCURRED. THE EXTENDED NEEDLE DAMAGED THE SCOPE. 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