BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1834321 · Received September 14, 2010

    Report

    Report Number
    3005099803-2010-03950
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED THAT THE TIP WAS BENT OUTSIDE THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583040 13523995

    Patients

    Seq Age Sex Outcome Treatment
    1