BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYPECTOMY SNARE

    MDR report key: 1944265 · Received January 3, 2011

    Report

    Report Number
    3005099803-2010-05344
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KNS
    PMA / PMN Number
    K810336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE TIP OF THE SNARE LOOP WAS DEFORMED, BUT THE LOOP EXTENDED AND RETRACTED WITHIN SPECIFICATION. THE DEVICE WAS SUBJECTED TO A RESISTANCE TEST AND WAS WITHIN SPECIFICATION (DEVICE READ AT 11.24 OHMS). THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT IT "WAS UNABLE TO CUT AND CAUTERIZE THE POLYP"; THE COMPLAINT WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05345 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II POLYPECTOMY SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, ALTHOUGH TISSUE WAS TURNING WHITE WHEN CAUTERY WAS ACTIVATED, THE SNARE WAS UNABLE TO CUT THE TARGET POLYP. THE CAUTERY PIN WAS SECURELY ATTACHED TO THE HANDLE, THE DEVICE HAD BEEN COMPLETELY UNCOILED PRIOR TO USE, AND NO BENDS OR KINKS WERE NOTED IN THE PLASTIC SHEATH. THE SNARE WAS SWITCHED OUT FOR ANOTHER CAPTIVATOR II POLYPECTOMY SNARE, BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR'S 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 GOOD.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05345 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II POLYPECTOMY SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, ALTHOUGH TISSUE WAS TURNING WHITE WHEN CAUTERY WAS ACTIVATED, THE SNARE WAS UNABLE TO CUT THE TARGET POLYP. THE CAUTERY PIN WAS SECURELY ATTACHED TO THE HANDLE, THE DEVICE HAD BEEN COMPLETELY UNCOILED PRIOR TO USE, AND NO BENDS OR KINKS WERE NOTED IN THE PLASTIC SHEATH. THE SNARE WAS SWITCHED OUT FOR ANOTHER CAPTIVATOR II POLYPECTOMY SNARE, BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR'S 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYPECTOMY SNARE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA M00561291 0013557187

    Patients

    Seq Age Sex Outcome Treatment
    1