BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAKES BILE DUCT DILATOR 3MM

    MDR report key: 230065 · Received July 2, 1999

    Report

    Report Number
    2916714-1999-00015
    Event Type
    Injury
    Date Received
    July 2, 1999
    Date of Event
    May 26, 1999
    Report Date
    July 2, 1999
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    EZM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXACT SURGICAL PROCEDURE UNKNOWN, HOWEVER, AN AESCULAP DILATOR WAS BEING USED WHEN THE DISTAL TIP FRACTURED AND LODGED IN BILIARY DUCT. RETRIEVAL OF FRACTURED TIP WAS UNSUCCESSFUL AND EVENT PROLONGED SURGERY TIME. PT IS BEING MONITORED BY SURGEON ON OUTPATIENT BASIS AND NO COMPLICATIONS HAVE BEEN REPORTED. THIS EVENT TYPE IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAKES BILE DUCT DILATOR 3MM DILATOR EZM AESCULAP AG & CO. KG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R