BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE BIOPSY VALVE (STERILE)

    MDR report key: 19041473 · Received April 4, 2024

    Report

    Report Number
    3003637092-2024-00052
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 14, 2024
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    EOQ
    UDI-DI
    14953170152433
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1 ESTABLISHMENT NAME: (B)(6) MEDICAL CENTER. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE TO CORRECT THE FDA PRODUCT CODE TO EOQ.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, ROOT CAUSE COULD NOT BE IDENTIFIED ALTHOUGH IT CAN BE PRESUMED THAT IT WAS CAUSED BY OVERLOAD APPLIED TO THE SURROUNDING AREA. THE EVENTS CAN BE DETECTED/PREVENTED IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE: SECTION 9.4 AND 9.5. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SINGLE USE BIOPSY VALVE BROKE WHEN IT WAS PASSED THROUGH. THE ISSUE OCCURRED DURING AN UNIDENTIFIED, DIAGNOSTIC PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335116 SINGLE USE BIOPSY VALVE (STERILE) SINGLE USE BIOPSY VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-210 14953170152433
    522006 SINGLE USE BIOPSY VALVE (STERILE) SINGLE USE BIOPSY VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-210 14953170152433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown