BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE BILIARY STENT V

    MDR report key: 12340901 · Received August 19, 2021

    Report

    Report Number
    8010047-2021-10471
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 15, 2021
    Report Date
    August 19, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGE
    PMA / PMN Number
    K933200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION AND INVESTIGATION. DHR FOR THE PAST 1 YEARS FROM THE DATE OF THIS EVENT WAS CONFIRMED, SINCE THE LOT NUMBER OF THE DEVICE WAS UNKNOWN. THERE WERE NO ABNORMALITIES FOUND IN THE INSPECTION ITEMS RELATE TO THIS PHENOMENON. APPEARANCE. IT WAS ALSO CHECKED THE FOLLOWING ITEMS. IS THE MATERIAL OF THE STENT BODY AND ADHESIVE CHANGED? CONFIRMED WITH DRAWINGS, ACCEPTANCE INSPECTION RECORDS, AND 5M FLUCTUATION RECORDS FOR THE PAST 3 YEARS, THERE WAS NO CHANGE. IS THERE ANY CHANGE IN THE MANUFACTURING PROCESS RELATED TO FLAPS, ETC.? THERE WAS NO CHANGE WHEN I CHECKED THE DRAWINGS FOR THE PAST 3 YEARS AND THE 5M FLUCTUATION RECORD. ARE SIMILAR CASES OCCURRING AT OTHER FACILITIES? THE ACTUAL PRODUCT OF THE COMPONENT HAS BEEN DISCARDED, AND THE LOT IS UNKNOWN. HOWEVER, THE ACTUAL LOTS ARE ESTIMATED TO BE 0XK, 0YK, AND 0ZK FROM THE SHIPPING RECORD AND THE INFORMATION ON THE DETENTION PERIOD. THERE IS NO SIMILAR PROBLEM FROM OTHER FACILITIES AT 0XK, 0YK, 0ZK PREVIOUS SIMILAR CASES HAVE SHOWN THAT THE SIDE FLAPS POSSIBLY DETERIORATED DUE TO DIGESTIVE FLUID OR INTERNAL ENVIRONMENT OF THE PATIENT. THE SIDE FLAPS MIGHT HAVE DETERIORATED DUE TO THE CHEMICAL EFFECTS OF DIGESTIVE FLUID AND THE MECHANICAL EFFECTS OF PERISTALSIS, CAUSING THE SIDE FLAP DAMAGE. HOWEVER, THE SUBJECT DEVICE WAS NOT DELIVERED FOR INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE PHYSICIAN THAT DURING AN ENDOSCOPIC RETROGRADE COLANGIOPANCREATOGRAPHY USING THE SUBJECT DEVICE, THE STENT COULD BE PUT INSIDE THE PATIENT. HOWEVER, DURING FOLLOW UP, THE STENT FELL AND STRAYED INTO THE PATIENT WITHIN HALF A YEAR. IT TOOK ABOUT 2 HOURS TO RETRIEVE THE STRAYED STENT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239302 SINGLE USE BILIARY STENT V SINGLE USE BILIARY STENT FGE OLYMPUS MEDICAL SYSTEMS CORP. PBD-V621R-1005

    Patients

    Seq Age Sex Outcome Treatment
    1