BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2220715 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02929
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): OUTPUT POWER DROPPING. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND MANY AREAS OF DISCOLORATION, AS WELL AS SOME MINOR SCRATCHES PRESENT ON THE COVER. ALL KNOBS AND SWITCHES APPEARED TO FUNCTION PROPERLY. DURING ELECTRICAL EVALUATION IT WAS FOUND THAT THE MONOPOLAR OUTPUT WAS AT THE LOW END OF SPECIFICATION, BUT THE UNIT PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE AND MET ALL SPECIFICATIONS. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT "POWER DROPS TO 2W WHEN SET AT 40W IN THE MONOPOLAR MODE." 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 III ELECTROSURGICAL UNIT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (DATE PERFORMED UNKNOWN). ACCORDING TO THE COMPLAINANT, THE POWER LEVEL REPEATEDLY DROPPED FROM 40W TO 2W DURING THE PROCEDURE, AND THE ISSUE WAS ISOLATED TO THE DEVICE'S "CUT" MODE. THE GENERATOR WAS BEING USED TO PERFORM A SPHINCTEROTOMY, BUT IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (DATE PERFORMED UNKNOWN). ACCORDING TO THE COMPLAINANT, THE POWER LEVEL REPEATEDLY DROPPED FROM 40W TO 2W DURING THE PROCEDURE, AND THE ISSUE WAS ISOLATED TO THE DEVICE'S "CUT" MODE. THE GENERATOR WAS BEING USED TO PERFORM A SPHINCTEROTOMY, BUT IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540200

    Patients

    Seq Age Sex Outcome Treatment
    1