BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYPECTOMY SNARE

    MDR report key: 1904273 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04753
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 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

    THE RETURNED DEVICE PRESENTED WITH A KINK APPROXIMATELY 5CM FROM THE DISTAL END; HOWEVER IT WAS FOUND TO RETRACT AND EXTEND WITHIN SPECIFICATION. THE DEVICE WAS SUBJECTED TO AN ELECTRICAL RESISTANCE TEST AND WAS WITHIN THE SPECIFICATION OF 20 OHMS (DEVICE READ AT 10.63 OHMS). THE CONDITION OF THE DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT CAUTERY DID NOT WORK; 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 SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CAPTIVATOR II POLYPECTOMY SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON A (B)(6) MALE PATIENT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A CURRENT FAILURE OCCURRED WHEN THE SNARE WAS CONNECTED TO A COMPETITOR'S GENERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II POLYPECTOMY 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

    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, DURING THE PROCEDURE, A CURRENT FAILURE OCCURRED WHEN THE SNARE WAS CONNECTED TO A COMPETITOR'S GENERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II POLYPECTOMY 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 0013664532

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR