BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE BILIARY STENT V

    MDR report key: 14466142 · Received May 21, 2022

    Report

    Report Number
    8010047-2022-08685
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    September 23, 2021
    Report Date
    December 6, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGE
    UDI-DI
    04953170186370
    PMA / PMN Number
    K933200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION PROVIDED BY THE LEGAL MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT LOT INDICATED NO ANOMALY WITH THE EVENT-RELATED ITEMS. THE RECORD INCLUDES THE FOLLOWING: PROCESS INSPECTION SHEET, QUALITY INSPECTION SHEET. ALTHOUGH THERE WERE NO ANOMALIES IDENTIFIED IN THE DHR, THE CAPA (PREVIOUSLY MENTIONED IN THE INITIAL REPORT) WAS OPENED BECAUSE OF THE ACTUAL DISCREPANCY BETWEEN THE BOX AND ITS CONTENTS DUE TO MANUFACTURING CAUSES. A SEARCH WAS PERFORMED TO DETERMINE WHETHER THERE WERE OTHER COMPLAINTS RECEIVED FOR MISPACKAGING OF THE PRODUCTS, AND NO OTHER COMPLAINTS WERE RECEIVED FOR THIS ISSUE. ACTIVITIES HAVE BEEN TAKEN TO INVESTIGATE THIS EVENT AND PREVENT REOCCURRENCE OF THIS EVENT IN THE FUTURE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. EVALUATION OF THE DEVICE FOUND THE PRODUCT AND LABELING DID NOT MATCH. THE PRODUCT LABEL, BARCODE LABEL, AND TRIPLE STICKER SHOWED PBD-203-0707, AND THE PACK PRINTING AND PRODUCT BODY SHOWED PBD-203-0704. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, IT IS LIKELY THE PRODUCT LISTED ON THE CARTON DID NOT MATCH THE PRODUCT BODY DUE TO MULTIPLE PRODUCTS BEING PLACED IN ONE STERILIZATION BASKET AND STERILIZED AT THE SAME TIME. THE PBD-203-0704 WAS THEN PACKED AS PBD-203-0707, BECAUSE PBD-203-0704 WAS MIXED IN WITH THE PBD-203-0707. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. G3: INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS ISSUE AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE (B)(6) 2021.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN INSPECTING THE BILIARY STENT BEFORE USE DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE CONTENTS OF THE BOX WERE DIFFERENT FROM THE OUTER BOX. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521717 SINGLE USE BILIARY STENT V SINGLE USE BILIARY STENT FGE OLYMPUS MEDICAL SYSTEMS CORP. PBD-203-0707 0XKA 04953170186370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown