BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1981509 · Received February 8, 2011

    Report

    Report Number
    3005099803-2011-00325
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE SERIAL NUMBER; THEREFORE, THE DEVICE MANUFACTURED DATE IS UNKNOWN.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

    CORRECTION: AN ENDOSTAT I ELECTROSURGICAL UNIT WAS USED, NOT AN ENDOSTAT III AS PREVIOUSLY REPORTED. CORRECTION: NO UPN EXISTS FOR ENDOSTAT I ELECTROSURGICAL UNITS. THE SERIAL NUMBER OF THE COMPLAINT UNIT WAS CONFIRMED TO BE (B)(4). ADDITIONAL INFORMATION: THE DEVICE MANUFACTURED DATE IS 04/13/1991.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED ON (B)(6), 2011 (IT IS UNKNOWN IF THE UNIT WAS USED DURING A PROCEDURE). ACCORDING TO THE COMPLAINANT, THE UNIT WAS NOT OPERATIONAL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING 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 ON (B)(6) 2011 (IT IS UNKNOWN IF THE UNIT WAS USED DURING A PROCEDURE). ACCORDING TO THE COMPLAINANT, THE UNIT WAS NOT OPERATIONAL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING 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 ELECTROSURGICAL UNIT UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH UNK626

    Patients

    Seq Age Sex Outcome Treatment
    1