BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1880881 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04415
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH SOME MINOR SCRATCHES ON THE COVER, BUT WAS OTHERWISE IN FAIR PHYSICAL CONDITION. ALL KNOBS AND SWITCHES ON THE UNIT FUNCTIONED AS INTENDED, AND ELECTRICALLY, THE UNIT WAS WITHIN SPECIFICATION. ALL CONNECTIONS WITHIN THE UNIT WERE CHECKED AND VERIFIED TO BE IN GOOD WORKING ORDER. THE TUBING OF THE PUMP WAS CLAMPED OFF WHILE THE IRRIGATION WAS ACTIVATED, AND THE PUMP STILL FUNCTIONED PROPERLY. THE FOOTSWITCH WIRE WAS ALSO MANIPULATED TO CHECK FOR POTENTIAL ISSUES, BUT NONE WERE FOUND. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT OF PUMPING ISSUES. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE IRRIGATION SYSTEM ON THE UNIT DID NOT PROPERLY CIRCULATE FLUID; THE PUMP TURNED VERY SLOWLY. IN ORDER TO CIRCUMVENT THE PROBLEM, THE COMPLAINANT USED A 60CC SYRINGE TO INJECT FLUID. THERE WERE NO REPORTED PATIENT ISSUES AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETE WITH THIS DEVICE. AT THE CONCLUSION OF THE PROCEDURE, THE COMPLAINANT NOTED THAT A RUBBER MECHANISM WITHIN THE PUMP APPEARED TO BE WORN DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT ELECTROSURGICAL UNIT UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540800

    Patients

    Seq Age Sex Outcome Treatment
    1