BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1931559 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05246
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    ON (B)(4), 2010, BSC BECAME AWARE OF A COMPLAINT INVOLVING THIS ENDOSTAT III ELECTROSURGICAL UNIT (REFER TO MFG'S REPORT NUMBER 3005099803-2010-05144) AND AN INJECTION GOLD PROBE (REFER TO MFG'S REPORT NUMBER 3005099803-2010-05145) USED DURING A PROCEDURE ON (B)(4) 2010 WHERE "THE INJECTION GOLD PROBE WAS GETTING TOO HOT". ON (B)(4) 2010, BSC BECAME AWARE THAT A SECOND EVENT OCCURRED, DURING ANOTHER PROCEDURE ON (B)(4) 2010, INVOLVING THE SAME ENDOSTAT III WHICH IS THE SUBJECT OF THIS REPORT AND A SENSATION MICRO OVAL SNARE (REFER TO MFG'S REPORT NUMBER 3005099803-2010-05247) WHERE " THE SNARE WAS GETTING TOO HOT". ON (B)(4) 2010, BSC RECEIVED CONFIRMATION FROM (B)(6)(NURSE AT (B)(6)) THAT THE ENDOSTAT III IN QUESTION HAD BEEN USED SINCE (B)(6) 2010 AND WAS REPORTED TO BE WORKING FINE. ON (B)(4) 2010, BSC RECEIVED ADDITIONAL INFORMATION THAT THE ENDOSTAT III HAD BEEN TESTED AT THE ACCOUNT AND WAS FOUND TO FUNCTION PROPERLY. (B)(6) (BIOMED TECHNICIAN AT (B)(6)) FURTHER INDICATED THAT THE UNIT HAD BEEN USED SUCCESSFULLY IN SEVERAL PROCEDURES SINCE (B)(6) 2010 AND WAS BEING RETAINED AT THE ACCOUNT FOR CONTINUED USE. AS THE ENDOSTAT, INJECTION GOLD PROBE, AND SNARE ARE NOT AVAILABLE FOR INVESTIGATION, THE ROOT CAUSE FOR THE REPORTED EVENTS THAT THE SNARE AND PROBE WERE "GETTING TOO HOT" CANNOT BE CONCLUSIVELY DETERMINED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05247 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT AND A SENSATION MICRO OVAL SNARE WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE GENERATOR WAS SET TO 35 IN THE "COAG" MODE. HOWEVER, THE SETTING WAS BROUGHT DOWN TO 30 WHEN THE PHYSICIAN THOUGHT THE SNARE WAS GETTING TOO HOT. THE PROCEDURE WAS COMPLETED WITH THIS ENDOSTAT III ELECTROSURGICAL 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 STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05247 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT AND A SENSATION MICRO OVAL SNARE WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE GENERATOR WAS SET TO 35 IN THE "COAG" MODE. HOWEVER, THE SETTING WAS BROUGHT DOWN TO 30 WHEN THE PHYSICIAN THOUGHT THE SNARE WAS GETTING TOO HOT. THE PROCEDURE WAS COMPLETED WITH THIS ENDOSTAT III ELECTROSURGICAL 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 STABLE.

    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 M00540200

    Patients

    Seq Age Sex Outcome Treatment
    1