BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 1941389 · Received December 29, 2010

    Report

    Report Number
    3005099803-2010-05318
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 A ELECTROCOAGULATION HEMOSTASIS PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INJECTION GOLD PROBE DEVICE DID NOT WORK PROPERLY. THEY INCREASED THE POWER TO 30W WITHOUT A SATISFYING RESULT. THEY REMOVED THE DEVICE FROM THE WORKING CHANNEL TO CHECK IT AND CLEAN IT, AND THEY REINSERTED THE DEVICE INTO THE WORKING CHANNEL. WHEN THE DEVICE CAME OUT OF THE WORKING CHANNEL, THEY SAW THAT THE ELECTRODE TIP HAD DETACHED FROM THE CATHETER; THE TIP WAS NOT RETRIEVED. ANOTHER INJECTION GOLD PROBE DEVICE WAS USED 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 STABLE.

    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 - MIAMI M00560150 13559039

    Patients

    Seq Age Sex Outcome Treatment
    1