BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX SPHINCTEROTOME

    MDR report key: 1221567 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-06024
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO MALFUNCTIONS THAT OCCURRED DURING THE PROCEDURE. IT WAS REPORTED TO THE BOSTON SCIENTIFIC CORPORATION THAT, DURING PREP, A JAGTOME RX SPHINCTEROTOME DEVICE WAS STUCK IN BOWED STATE (PATIENT GENDER, AGE, AND WEIGHT ARE UNK). THE DEVICE WAS NOT USED AND WAS REPLACED WITH A SECOND JAGTOME RX SPHINCTEROTOME DEVICE. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-06025 FOR A DESCRIPTION OF THE OTHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00573540 12005146

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK