BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SUCTION VALVE (STERILE)

    MDR report key: 18589683 · Received January 26, 2024

    Report

    Report Number
    3003637092-2024-00017
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    December 27, 2023
    Report Date
    May 7, 2024
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    EOQ
    UDI-DI
    14953170152426
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED, TO CORRECT THE FDA PRODUCT CODE TO EOQ.

    Additional Manufacturer Narrative · 0

    THE CLIENT WAS INFORMED BY THE COMPANY REPRESENTATIVE THAT THAT PRACTICE WAS NOT IN ACCORDANCE WITH THE PRODUCT AND IT WAS REQUESTED THAT THE CLIENT DISPOSES THE DEVICE AFTER USE AND THAT A NEW ONE BE PLACED WITH THE ENDOSCOPE BEFORE THE EXAMINATION. THE DEVICE WAS NOT RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. THE INITIAL MEDWATCH REPORTED THE CLIENT REUSED THE SINGLE-USE PISTONS ON THE BRONCHOSCOPES BY DISASSEMBLING THEM AND PASSING THEM THROUGH THE PERACETIC ACID (PAA) WASHERS. HOWEVER, PER THE LEGAL MANUFACTURER, THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE ESTIMATION, THE SINGLE-USE PISTONS OF THE BRONCHOSCOPES, THE CLIENT REUSED THE SINGLE-USE PISTONS ON THE BRONCHOSCOPES BY DISASSEMBLING THEM AND PASSING THEM THROUGH THE PEREACETIC ACID (PAA) WASHERS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973472 SINGLE USE SUCTION VALVE (STERILE) SINGLE USE SUCTION VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-209 UNKNOWN 14953170152426
    671448 SINGLE USE SUCTION VALVE (STERILE) SINGLE USE SUCTION VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-209 UNKNOWN 14953170152426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown