BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 2768899 · Received September 25, 2012

    Report

    Report Number
    8010047-2012-00347
    Event Type
    Other
    Date Received
    September 25, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 27, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    FDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT BUT OMSC COULD NOT OBTAIN THE CAUSE OF BLEEDING, AND THE INFO WHICH INDICATE RELATIONSHIP BETWEEN BLEEDING AND THE SUBJECT DEVICE. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OMSC FOR EVAL. THERE WERE NO ABNORMALITIES RELATED TO THE PHENOMENON IN THE MANUFACTURING RECORD OF THE SUBJECT DEVICE. OMSC CONCLUDED THAT THE BLEEDING WAS LIKELY DUE TO THE PT CONDITION BECAUSE BLEEDING ACCOMPANYING EST ARE REPORTED AS HAPPENING ACCIDENTALLY IN CLINICAL ARTICLES. THIS IS ONE OF TWO REPORTS. PLEASE ALSO REFERENCE 8010047-2012-00317. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPHINCTEROTOMY, THE CUTTING WIRE OF A (B)(4) WAS BROKEN. THE USER REPORTEDLY TRIED TO CONTINUED THE PROCEDURE WITH THE SUBJECT DEVICE; (B)(4), HOWEVER, BLEEDING OF THE TARGET SITE OCCURRED AFTER THE PROCEDURE RE-STARTED. THE USER REPORTEDLY TRIED TO STOP THE BLEEDING USING UNCERTAIN MEANS WITHOUT SUCCESS. THE PT WAS SAID TO HAVE BEEN TRANSFERRED TO LAPAROSCOPIC CHOLECYSTECTOMY AND THE BLEEDING WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE 3-LUMEN SPHINCTEROTOME V SPHINCTEROTOME FDR OLYMPUS MEDICAL SYSTEMS CORP KD-V411M-0725 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization