BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1852512 · Received October 4, 2010

    Report

    Report Number
    3005099803-2010-04171
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    A VISUAL EVALUATION OF THE RETURNED UNIT FOUND A LARGE AMOUNT OF PAINT MISSING FROM TOP OF THE COVER AND SOME MINOR SCRATCHES ON THE CHASSIS OF THE UNIT. THE PUMP ON THE UNIT IS RUSTY AND THE CLAMP ON THE PUMP WHICH HOLDS THE HOSE ASSEMBLY IS BROKEN. ALL KNOBS AND SWITCHES APPEAR TO FUNCTION PROPERLY. THE UNIT PASSED THE ENDOSTAT II RETURN EVALUATION PROCEDURE FOR ALL ELECTRICAL OUTPUTS SPECIFICATIONS BUT FAILED THE IRRIGATION PART OF THE TEST. THERE WAS NO IRRIGATION DUE TO THE BROKEN CLAMP ON THE PUMP. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A POLYPECTOMY PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO CAUTERIZE THE POLYP TISSUE, THERE WAS NO OUTPUT. ADDITIONALLY, THE PHYSICIAN NOTED THAT THERE WAS AN "INTERNAL GLOW" WHEN PRESSING THE FOOT SWITCH. THE PHYSICIAN SUSPECTED THAT THERE MUST HAVE BEEN AN INTERNAL SHORT CIRCUIT, OR A COMPONENT FAILURE. THE COMPLAINANT CONFIRMED THAT THERE WERE NO ISSUES WITH THE FOOT SWITCH OR ANY OF THE OTHER ACCESSORIES. THE PHYSICIAN WAS ABLE TO COMPLETE PROCEDURE BY USING A COLD SNARE AND HEMOCLIPS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A POLYPECTOMY PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO CAUTERIZE THE POLYP TISSUE, THERE WAS NO OUTPUT. ADDITIONALLY, THE PHYSICIAN NOTED THAT THERE WAS AN ¿INTERNAL GLOW¿ WHEN PRESSING THE FOOT SWITCH. THE PHYSICIAN SUSPECTED THAT THERE MUST HAVE BEEN AN INTERNAL SHORT CIRCUIT, OR A COMPONENT FAILURE. THE COMPLAINANT CONFIRMED THAT THERE WERE NO ISSUES WITH THE FOOT SWITCH OR ANY OF THE OTHER ACCESSORIES. THE PHYSICIAN WAS ABLE TO COMPLETE PROCEDURE BY USING A COLD SNARE AND HEMOCLIPS. 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.

    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 M00540800

    Patients

    Seq Age Sex Outcome Treatment
    1