BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION? SHORT THROW

    MDR report key: 3902377 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02399
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND NO ANOMALIES. ELECTRICAL RESISTANCE TESTING WAS PERFORMED AND FOUND THE DEVICE WITHIN MANUFACTURING SPECIFICATIONS. THE COMPLAINT THAT THE DEVICE DID NOT PERFORM COAGULATION WAS NOT CONFIRMED. THE RETURNED DEVICE SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUES, NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4) FOR THE REPORTED EVENT: NO ELECTRIC CURRENT. 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 THAT A SENSATION SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS USED TO REMOVE FIVE POLYPS SUCCESSFULLY. HOWEVER, THE DEVICE FAILED TO TRANSMIT CURRENT WHEN THE USER ATTEMPTED TO REMOVE A SIXTH POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS USED TO REMOVE FIVE POLYPS SUCCESSFULLY. HOWEVER, THE DEVICE FAILED TO TRANSMIT CURRENT WHEN THE USER ATTEMPTED TO REMOVE A SIXTH POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379753 SENSATION? SHORT THROW POLYPECTOMY SNARE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK657

    Patients

    Seq Age Sex Outcome Treatment
    1