BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 2032278 · Received March 29, 2011

    Report

    Report Number
    3005099803-2011-01106
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE LOT NUMBER IS S07973. ADDITIONAL INFORMATION: DEVICE MANUFACTURED DATE IS 10/24/2007. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND IT TO BE IN GOOD PHYSICAL CONDITION, AND IT FUNCTIONED PROPERLY DURING MECHANICAL TESTING. WIRES WERE MANIPULATED WHILE POWER WAS ACTIVE AND NO PROBLEMS WERE FOUND. THE FOOT SWITCH AND CONSOLE BOTH PASSED THE ENDOSTAT II RETURN EVALUATION PROCEDURE. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT ¿BIPOLAR OUTPUT WAS NOT WORKING"; THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01105 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT AND AN ENDOSTAT II FOOT SWITCH WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS ATTEMPTING TO CAUTERIZE WITH A GOLD PROBE WHEN IT WAS NOTED THAT THE GENERATOR'S BIPOLAR OUTPUT WAS NOT FUNCTIONING. THE PHYSICIAN SWITCHED TO A NEW GOLD PROBE WITH NO CHANGE; THEREFORE THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GENERATOR AND FOOT SWITCH. FOLLOWING THE PROCEDURE, THE BIOMED AT THE ACCOUNT PERFORMED A DIAGNOSTIC TEST ON THE GENERATOR AND CONFIRMED NO BIPOLAR OUTPUT. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01105 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT AND AN ENDOSTAT II FOOT SWITCH WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS ATTEMPTING TO CAUTERIZE WITH A GOLD PROBE WHEN IT WAS NOTED THAT THE GENERATOR'S BIPOLAR OUTPUT WAS NOT FUNCTIONING. THE PHYSICIAN SWITCHED TO A NEW GOLD PROBE WITH NO CHANGE; THEREFORE THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GENERATOR AND FOOT SWITCH. FOLLOWING THE PROCEDURE, THE BIOMED AT THE ACCOUNT PERFORMED A DIAGNOSTIC TEST ON THE GENERATOR AND CONFIRMED NO BIPOLAR OUTPUT. 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 M00540740 S07973

    Patients

    Seq Age Sex Outcome Treatment
    1