BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 2 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2399929 · Received January 5, 2012

    Report

    Report Number
    3005099803-2011-04518
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 2, 2011
    Report Date
    December 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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

    (B)(4). THE PHYSICIAN WAS PERFORMING A COLONOSCOPY WITH POLYPECTOMY ON (B)(6) 2011 WHEN A LOUD BUZZING SOUND WAS NOTED TO BE EMITTING FROM THE CONSOLE. THE NOISE WAS REPORTEDLY COMING FROM INSIDE THE UNIT AND WAS DISTINCT FROM THE ACTIVE TONE. THE PROCEDURE WAS COMPLETED USING THIS DEVICE, ALTHOUGH THE PHYSICIAN ALSO REPORTED THAT THE POWER OUTPUT SEEMED TO BE LOWER THAN USUAL. NO ADVERSE PATIENT CONSEQUENCES AROSE DUE TO THIS EVENT, HOWEVER, AND THE PATIENT WAS FINE FOLLOWING THE PROCEDURE. OPERATOR OF DEVICE: PHYSICIAN. INITIAL REPORTER: DR. (B)(6), PHYSICIAN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE CONSOLE EMITTED A LOUD BUZZING SOUND. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE CONSOLE EMITTED A LOUD BUZZING SOUND. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT 2 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540800

    Patients

    Seq Age Sex Outcome Treatment
    1