BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 1923694 · Received December 14, 2010

    Report

    Report Number
    3005099803-2010-05125
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. A SHIP HISTORY REVIEW WAS PERFORMED IN ORDER TO IDENTIFY THE MOST PROBABLE LOTS INVOLVED IN THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE PROBABLE LOTS WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE PROBABLE LOTS.

    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 #3005099803-2010-05126 FOR A DESCRIPTION OF THE OTHER DEVICE. THIS REPORT IS FOR THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO INJECTION GOLD PROBE DEVICES WERE INTENDED FOR USE FOR HEMOSTASIS OF A BLEEDING ULCER IN THE STOMACH. ACCORDING TO THE COMPLAINANT, THE INJECTION GOLD PROBE DEVICE WAS CONNECTED TO THE DIATHERMY MACHINE. WHEN THE PHYSICIAN TRIED TO APPLY CURRENT, THE PROBE APPEARED NOT CONDUCTING CURRENT TO THE TIP OF THE PROBE. THE PHYSICIAN REPLACED THIS DEVICE ANOTHER PROBE AND HAD THE SAME PROBLEM. USING THE SAME GENERATOR, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE THIRD INJECTION GOLD PROBE, WHICH WORKED WITHOUT INCIDENT. 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 GOOD.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1