BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS DIRECT VISUALIZATION PROBE AND OCULA

    MDR report key: 798530 · Received December 21, 2006

    Report

    Report Number
    6000048-2006-00643
    Event Type
    Injury
    Date Received
    December 21, 2006
    Date of Event
    November 27, 2006
    Report Date
    November 28, 2006
    Manufacturer
    MYRIAD FIBER IMAGING TECHNOLOGIES, INC.
    Product Code
    KOG
    PMA / PMN Number
    K052194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION 6: G3 - STUDY; CLINICAL TRIAL. INFO SUPPLIED WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. THIS DEVICE HAS NOT BEEN RECEIVED BY THIS MFR; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEN THIS DEVICE AND THE CAUSE OF THIS EVENT. THE PHYSICIAN/INVESTIGATOR HAS DEEMED THAT THE "BRADYCARDIA WAS RELATED TO ANESTHESIA/SEDATION USED DURING THE PROCEDURE." HE HAS ALSO DETERMINED THAT "BOTH COMPLICATIONS WERE PROBABLY RELATED TO THE SPYGLASS PROCEDURE AND UNLIKELY RELATED TO THE SPYGLASS DEVICE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE UNDERWENT ERCP WITH SPYGLASS ENDOSCOPE FOR DIAGNOSIS OF AN INDETERMINATE STRICTURE IN THE BILE DUCT (RIGHT MAIN). UPON INTRODUCTION OF THE SCOPE, THE PT EXPERIENCED BRADYCARDIA. THE PT'S HEART RATE LOWERED TO 28 BEATS PER MINUTE AND LASTED FOR 60 SECONDS. THIS WAS RESOLVED BY ADMINISTERING ROBINOL (0.2 MG ONE TIME BY IV). AFTER THE PROCEDURE, THE PT EXPERIENCED PANCREATITIS. ASSOCIATED SIGNS AND SYMPTOMS WERE ABDOMINAL PAIN AND AN INCREASE OF: LFTS, AMY, AND LIPASE. THE ACTIONS TAKEN WERE OBSERVATION (HOSPITALIZATION) AND ADMINISTRATION OF INTRAVENOUS FLUIDS. THE SEVERITIES OF BOTH COMPLICATIONS WERE RATED BY THE PHYSICIAN AS "MILD." THE PT WAS REPORTED TO HAVE BEEN IN "FINE CONDITION" FOLLOWING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYGLASS DIRECT VISUALIZATION PROBE AND OCULA KOG KOG MYRIAD FIBER IMAGING TECHNOLOGIES, INC. M00546231 0PD5121303

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R