BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7288968 · Received February 21, 2018

    Report

    Report Number
    MW5075424
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    December 21, 2017
    Report Date
    February 19, 2018
    Manufacturer
    HOYA CORPORATION, PENTAX DIVISION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    UNEVENTFUL ERCP WAS PERFORMED FOR MIGRATION OF PRIOR COMMON BILE DUCT STENT PLACED IN (B)(6) 2017. FOLLOWING THE PROCEDURE, DURING CLEANING OF THE SCOPE, A PANCREATIC STENT WAS FOUND IN THE SUCTION CHANNEL OF THE SCOPE AND RETRIEVED WITH A TWEEZERS. NOTE THAT A PANCREATIC STENT HAD NOT BEEN PLACED, OR ATTEMPTED TO BE PLACED, IN THIS PT DURING THIS PROCEDURE OR PRIOR PROCEDURES. AFTER PRIOR USE SEVERAL WEEKS EARLIER, THE SCOPE WAS DOCUMENTED AS BEING CLEANED PER MFR'S RECOMMENDATIONS. NOTE THAT THE DATE BELOW FOR RETURN TO MFR IS APPROXIMATE. PER REPORT, THE MFR DID NOT FIND ANY PROBLEMS WITH THE SCOPE AND IT WAS RETURNED TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128141 PENTAX DUODENOSCOPE FDT HOYA CORPORATION, PENTAX DIVISION 3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR