BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 2091780 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01673
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND SOME SCRATCHES AND DECALS ON THE COVER; OTHERWISE THE UNIT APPEARED TO BE IN GOOD PHYSICAL CONDITION. ALL KNOBS AND SWITCHES FUNCTIONED PROPERLY. THE FOOT SWITCH FUNCTIONED PROPERLY DURING ELECTRICAL EVALUATION, HOWEVER, IT WAS FOUND THAT THE MONOPOLAR CONNECTOR ON THE FRONT BEZEL OF THE CONSOLE WOULD NOT ACCEPT THE ACTIVE CORD CONNECTOR PROPERLY. THE SPRING CLIP IN THE MONOPOLAR CONNECTOR HAD BEEN PUSHED OPEN SUCH THAT NO CONNECTION COULD BE MADE TO THE ACTIVE CONNECTOR. THE COMPLAINT THAT THE SYSTEM WOULD NOT DELIVER ENERGY IN MONOPOLAR MODES WAS CONFIRMED. THE SPRING CLIP IN THE MONOPOLAR CONNECTOR OF THE CONSOLE WAS REPLACED, AFTER WHICH THE SYSTEM FUNCTIONED PROPERLY. 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 SERIAL NUMBER.

    Additional Manufacturer Narrative · 1

    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 # 3005099803-2011-01674 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT AND AN ENDOSTAT III FOOT SWITCH WERE USED DURING A COLONOSCOPY PROCEDURE (WITH POLYPECTOMY) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, POWER DELIVERY COULD NOT BE ACHIEVED AND THE ISSUE PERSISTED WHEN ACCESSORY DEVICES WERE REPLACED; THREE SNARES AND TWO ACTIVE CORDS WERE USED. THE FOOT SWITCH WAS NOT REPLACED, HOWEVER, AND NO SYSTEM FAULT ALARMS WERE NOTED. A COMPETITOR'S GENERATOR WAS USED TO COMPLETE THE PROCEDURE. FOLLOWING THE PROCEDURE, THE UNIT WAS TESTED WITH THE SAME FOOT SWITCH AND THE ISSUE WITH POWER DELIVERY WAS CONFIRMED. IT WAS REPORTED THAT BOTH ACTIVE CORDS HAVE BEEN IN USE SINCE THE PROCEDURE AND THE ACCOUNT ALLEGES NO MALFUNCTION OF THESE DEVICES. 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 # 3005099803-2011-01674 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT AND AN ENDOSTAT III FOOT SWITCH WERE USED DURING A COLONOSCOPY PROCEDURE (WITH POLYPECTOMY) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, POWER DELIVERY COULD NOT BE ACHIEVED AND THE ISSUE PERSISTED WHEN ACCESSORY DEVICES WERE REPLACED; THREE SNARES AND TWO ACTIVE CORDS WERE USED. THE FOOT SWITCH WAS NOT REPLACED, HOWEVER, AND NO SYSTEM FAULT ALARMS WERE NOTED. A COMPETITOR'S GENERATOR WAS USED TO COMPLETE THE PROCEDURE. FOLLOWING THE PROCEDURE, THE UNIT WAS TESTED WITH THE SAME FOOT SWITCH AND THE ISSUE WITH POWER DELIVERY WAS CONFIRMED. IT WAS REPORTED THAT BOTH ACTIVE CORDS HAVE BEEN IN USE SINCE THE PROCEDURE AND THE ACCOUNT ALLEGES NO MALFUNCTION OF THESE DEVICES. 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 M00540200

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR