BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR¿

    MDR report key: 2993184 · Received March 7, 2013

    Report

    Report Number
    3005099803-2013-01516
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE CAUTERY PIN IN THE CORRECT POSITION. THE DEVICE PASSED THE ELECTRICAL TEST AND WAS WITHIN THE RESISTANCE SPECIFICATIONS. THE COMPLAINT WAS NOT CONFIRMED, THE COMPLAINT DEVICE SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT OF WIRE FAILURE TO CAUTERIZE. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT A CAPTIVATOR SMALL HEXAGONAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPRESSED THE FOOT PEDAL TO CAUTERIZE THE POLYP, THE MONITOR BECAME "FUZZY". THEN THE SNARE REPORTEDLY STOPPED CAUTERIZING. THE DEVICE WAS REMOVED FROM SERVICE AND ANOTHER CAPTIVATOR SNARE WAS USED TO COMPLETE THE PROCEDURE ALONG WITH THE ORIGINAL NON-BSC GENERATOR. IT WAS CONFIRMED THAT THE MONITOR WAS "FUZZY" FOR THE REMAINDER OF THE PROCEDURE. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CAPTIVATOR SMALL HEXAGONAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPRESSED THE FOOT PEDAL TO CAUTERIZE THE POLYP, THE MONITOR BECAME "FUZZY". THEN THE SNARE REPORTEDLY STOPPED CAUTERIZING. THE DEVICE WAS REMOVED FROM SERVICE AND ANOTHER CAPTIVATOR SNARE WAS USED TO COMPLETE THE PROCEDURE ALONG WITH THE ORIGINAL NON-BSC GENERATOR. IT WAS CONFIRMED THAT THE MONITOR WAS "FUZZY" FOR THE REMAINDER OF THE PROCEDURE. 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
    96772 CAPTIVATOR¿ SMALL HEXAGONAL - STIFF FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562451 15686234

    Patients

    Seq Age Sex Outcome Treatment
    1