BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYPECTOMY SNARE

    MDR report key: 2893737 · Received January 2, 2013

    Report

    Report Number
    3005099803-2013-00023
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K810336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE UPN OR LOT NUMBER. THEREFORE, THE MANUFACTURE DATE IS UNKNOWN. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN RETAINED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT NEW ACTIVE CORDS WERE PURCHASED FOR THE ENDOSCOPY ROOMS AND THE NEW ACTIVE CORDS WERE TESTED WITH A SNARE AND THE ISSUE WAS RESOLVED. THEY BELIEVE THE ISSUE WAS THE OLD ACTIVE CORD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT AN ACTIVE CORD WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ACTIVE CORD WAS NOT CONNECTING TO THE SNARE PROPERLY. THE NURSE/TECH HAD TO HOLD THE ACTIVE CORD AND SNARE TOGETHER TO MAINTAIN CONNECTION. IT IS UNKNOWN IF THE ISSUE OCCURRED DUE TO THE SNARE OR THE ACTIVE CORD. HOWEVER, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS ACTIVE CORD AND SNARE. 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. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT AN ACTIVE CORD WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ACTIVE CORD WAS NOT CONNECTING TO THE SNARE PROPERLY. THE NURSE/TECH HAD TO HOLD THE ACTIVE CORD AND SNARE TOGETHER TO MAINTAIN CONNECTION. IT IS UNKNOWN IF THE ISSUE OCCURRED DUE TO THE SNARE OR THE ACTIVE CORD. HOWEVER, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS ACTIVE CORD AND SNARE. 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. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453 POLYPECTOMY SNARE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER UNK329

    Patients

    Seq Age Sex Outcome Treatment
    1