BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 2063433 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01246
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF DIFFICULTY CONNECTING. 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 INJECTION GOLD PROBE DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. HOWEVER, INVESTIGATION RESULTS OF THE ENDOSTAT III ELECTROSURGICAL UNIT, IN ASSOCIATED MFR REPORT #3005099803-2011-01240, CONFIRMED THAT THE BIPOLAR CONNECTOR WAS BROKEN; THE ROOT CAUSE WAS DETERMINED TO BE WEAR AND TEAR. AS A DEVICE EVALUATION CANNOT BE PERFORMED ON THE INJECTION GOLD PROBE DEVICE, IT CANNOT BE DETERMINED WHETHER OR NOT THE BROKEN BIPOLAR CONNECTOR WAS CAUSED BY AN ISSUE WITH THE INJECTION GOLD PROBE DEVICE.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2011-01240 FOR A DESCRIPTION OF THE OTHER DEVICE. THIS REPORT IS FOR THE INJECTION GOLD PROBE DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT AND AN INJECTION GOLD PROBE WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ON (B)(6) 2011, THE COMPLAINANT REPORTED THAT THE BIPOLAR CONNECTOR WAS DAMAGED ON THE GENERATOR. ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION . ON (B)(6) 2011, BSC RECEIVED ADDITIONAL INFORMATION AND BECAME AWARE THAT INJECTION GOLD PROBE DEVICE WAS ALSO USED DURING THIS PROCEDURE . ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BEING TREATED FOR A BLEED IN THE STOMACH. WHEN THE NURSE ATTEMPTED TO PLUG THE INJECTION GOLD PROBE INTO THE CONSOLE, THE FIT INTO THE BIPOLAR RECEPTACLE DID NOT FEEL FLUSH AS USUAL. THE NURSE MADE TWO ADDITIONAL ATTEMPTS TO PLUG IN THE INJECTION GOLD PROBE, AND WHEN IT WAS UNPLUGGED FOR THE THIRD TIME, THE BIPOLAR CONNECTOR AND PIECES OF METAL DETACHED FROM THE CONSOLE. TO COMPLETE THE PROCEDURE, EPINEPHRINE WAS INJECTED WITH A MICROVASIVE NEEDLE AND THE SITE WAS CLIPPED AS A PRECAUTION. 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
    1 INJECTION GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MIAMI UNK195

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR