BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2942351 · Received February 4, 2013

    Report

    Report Number
    3005099803-2013-00658
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):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 COMPLAINT DEVICE SHOWED THE UNIT HAD SOME MINOR SCRATCHES ON THE COVER. OTHERWISE THE UNIT APPEARED TO BE IN FAIR PHYSICAL CONDITION, AND ALL KNOBS AND SWITCHES FUNCTIONED PROPERLY. THE UNIT PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE AND WAS WITHIN ALL TEST PARAMETERS. THE COVER WAS REMOVED TO INVESTIGATE THE COMPLAINT OF A BURNING SMELL, AND IT WAS FOUND THAT CAPACITOR C54 ON THE TOP RF BOARD WAS CHARRED. THE BOARD WAS CLEANED, AFTER WHICH ELECTRICAL TESTING FOUND IT TO BE IN GOOD WORKING ORDER. CAPACITOR C54 WAS REPLACED, ALONG WITH CAPACITOR C53 (DUE TO ITS PROXIMITY TO C54). C54 IS ORIENTED IN PARALLEL WITH FOUR OTHER CAPACITORS; THEREFORE, ITS FAILURE DID NOT SIGNIFICANTLY IMPACT THE RESULTS OF THE ENDOSTAT III RETURN EVALUATION PROCEDURE. THE COMPLAINT WAS CONFIRMED; HOWEVER, THE ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE FOR THIS EVENT. 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 THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS TURNED ON DURING PREPARATION AND A BURNING SMELL WAS NOTICED. SINCE THIS WAS THE ONLY GENERATOR AVAILABLE, IT WAS USED TO SUCCESSFULLY PERFORM THE COLONOSCOPY PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6), 2013.ACCORDING TO THE COMPLAINANT, THE DEVICE WAS TURNED ON DURING PREPARATION AND A BURNING SMELL WAS NOTICED. SINCE THIS WAS THE ONLY GENERATOR AVAILABLE, IT WAS USED TO SUCCESSFULLY PERFORM THE COLONOSCOPY PROCEDURE.NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46437 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540200R0

    Patients

    Seq Age Sex Outcome Treatment
    1