BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2810093 · Received October 31, 2012

    Report

    Report Number
    3005099803-2012-05147
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT: GENERATOR FAILED TO DELIVER ENERGY. 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

    INVESTIGATION RESULTS VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE UNIT TO HAVE SOME MINOR SCRATCHES PRESENT ON COVER AND CHASSIS, OTHERWISE THE UNIT APPEARS TO BE IN GOOD PHYSICAL CONDITION. A MECHANICAL EVALUATION FOUND ALL THE KNOBS AND SWITCHES TO FUNCTION PROPERLY. ELECTRICAL EVALUATION FOUND THAT THE UNIT PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE AND IS WITHIN ALL TEST PARAMETERS. THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED SERIAL NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT AN ENDOSTAT III ELECTROSURGICAL GENERATOR WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN IN MONOPOLAR BLEND MODE, THE FOOT PEDAL WAS PRESSED AND NO ENERGY WAS DELIVERED TO THE SNARE. THE FOOT SWITCH AND ACTIVE CORD WERE SWITCHED OUT WITH THE SAME RESULT. THE CABLES AND GROUNDING PADS WERE CONFIRMED TO BE IN ORDER (ALL LIGHTS WERE WORKING PROPERLY AND NO PAD FAULT OR SYSTEM FAULT ALARMS WENT OFF) BEFORE THE PROCEDURE. ANOTHER GENERATOR WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME SNARE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT AN ENDOSTAT III ELECTROSURGICAL GENERATOR WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN IN MONOPOLAR BLEND MODE, THE FOOT PEDAL WAS PRESSED AND NO ENERGY WAS DELIVERED TO THE SNARE. THE FOOT SWITCH AND ACTIVE CORD WERE SWITCHED OUT WITH THE SAME RESULT. THE CABLES AND GROUNDING PADS WERE CONFIRMED TO BE IN ORDER (ALL LIGHTS WERE WORKING PROPERLY AND NO PAD FAULT OR SYSTEM FAULT ALARMS WENT OFF) BEFORE THE PROCEDURE. ANOTHER GENERATOR WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME SNARE. 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 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