BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1771693 · Received July 27, 2010

    Report

    Report Number
    3005099803-2010-03312
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    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, WHEN THE ENDOSTAT UNIT IS TRIGGERED, THE PHYSICIAN GETS INTERFERENCE ON THE VIDEO MONITORING SYSTEM USED TO VISUALIZE THE PROCEDURE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THIS UNIT. 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 FINE. FURTHERMORE, THE COMPLAINANT HAS TESTED THE UNIT, AND THERE ARE NO ISSUES WITH THE OUTPUT GENERATED. THE COMPLAINANT ALSO NOTED THAT THIS PROBLEM HAPPENS IN ONLY ONE OF THE PROCEDURE ROOMS, SO THEY SUSPECT IS MAY BE AN ISOLATED GROUNDING ISSUE.

    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 M0054080R0

    Patients

    Seq Age Sex Outcome Treatment
    1