BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PJF-160 RENTAL (DMY)

    MDR report key: 17334109 · Received July 17, 2023

    Report

    Report Number
    9610595-2023-10199
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 5, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170433498
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE SITE TO ANSWER QUESTIONS THE CUSTOMER HAD. THE CUSTOMER NOTED THE DUODENOSCOPE WAS BEING REPROCESSED IN THE OER-ELITE SINCE THEY DID NOT WANT THE SCOPES TO LEAVE THE DEPARTMENT. THE SCOPE WAS RARELY USED AND WAS PRIMARILY BEING REPROCESSED DUE TO THE EXPIRATION OF THEIR HANG TIME. THE ESS INDICATED THE DUODENOSCOPE WAS NOT COMPATIBLE WITH THE OER-ELITE AND NEEDED TO BE TAKEN TO THE STERILE PROCESSING DEPARTMENT FOR ETO OR REPROCESSED USING AN OER-PRO PER THE INSTRUCTION FOR USE. THE ESS THE CUSTOMER THAT THE SCOPE WAS NOT COMPATIBLE WHEN SCANNED WITH THE OER-ELITE. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S 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, THE ROOT CAUSE OF THE IMPROPER REPROCESSING WAS A DIFFERENT PROCEDURE THAN WHAT OLYMPUS RECOMMENDED IN DEVICE HANDLING AND REPROCESSING STEPS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DUODENOSCOPE WAS INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663671 PJF-160 RENTAL (DMY) DUODENO VIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. PJF-160 04953170433498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown