BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE BILIARY DRAINAGE STENT V

    MDR report key: 9719061 · Received February 18, 2020

    Report

    Report Number
    8010047-2020-01375
    Event Type
    Injury
    Date Received
    February 18, 2020
    Report Date
    February 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. SINCE THE LOT NO. IS UNKNOWN, THE MANUFACTURING HISTORY RECORD (DHR) COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES WHICH PASSED THE FOLLOWING INSPECTIONS. DIMENSION OF THE STENT. APPEARANCE OF THE STENT. THERE WAS NO MALFUNCTION REPORT OF THE SUBJECT DEVICE CONCERNING THE EVENT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    ON JANUARY 22ND, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿METAL STENT IMPACTION IN SCOPE CHANNEL SUCCESSFULLY RESCUED BY ARGON PLASMA COAGULATION WITH DOUBLE SCOPE METHOD¿. THE LITERATURE REPORTED THAT A PATIENT WITH A HISTORY OF MALIGNANT BILIARY OBSTRUCTION CAUSED BY UNRESECTABLE INTRADUCTAL PAPILLARY MUCINOUS CARCINOMA (IPMC) WAS ADMITTED FOR CHOLANGITIS DUE TO PLASTIC STENT OCCLUSION. THE ARTICLE DOES NOT DIRECTLY INDICATE THAT OLYMPUS PLASTIC STENT WAS USED FOR THE PATIENT. HOWEVER, IT IS LIKELY THAT OLYMPUS PLASTIC STENT WAS USED FOR THE PATIENT BASED ON THE SALES HISTORY FOR THE USER FACILITY. ACCORDING TO THE NUMBER OF THE COMPLICATION AND THE NUMBER OF OLYMPUS DEVICE WHICH MIGHTY HAVE CONTRIBUTED TO THE COMPLICATION, OMSC IS SUBMITTING ONE MEDICAL DEVICE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182279 SINGLE USE BILIARY DRAINAGE STENT V SINGLE USE BILIARY STENT FGE OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other