BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PJF-160 RENTAL (DMY)

    MDR report key: 16874013 · Received May 4, 2023

    Report

    Report Number
    9610595-2023-07140
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    March 9, 2023
    Report Date
    June 1, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170433498
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 HEALTH EFFECT- CLINICAL CODE: VERY HIGH LIPASE POST PROCEDURE. THE SUBJECT DEVICE WAS A RETURNED OLYMPUS ASSET. DURING THE EVALUATION OF THE DEVICE, THE USER'S REPORT WAS NOT CONFIRMED BUT LOW ANGULATION WAS OBSERVED. NO OTHER EVALUATION FINDINGS NOTED DURING THE EVALUATION OF THE DEVICE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT HAS BEEN REPORTED BY THE IMPORTER UNDER THIS MDR#2429304 - 2023 - 00064.

    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. IT HAS BEEN OVER 12 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE OPERATOR OF THE DEVICE HAD DIFFICULTY MANIPULATING THE ELEVATOR CONTROL LEVER BECAUSE THE FORCEPS ELEVATOR WAS DIFFICULT TO RAISE DUE TO THE NARROW INTESTINAL TRACT OF THE PEDIATRIC PATIENT (LESS THAN 1 YEAR OLD). HOWEVER, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) IN THE FOLLOWING SECTION: ¿CHAPTER 3 PREPARATION AND INSPECTION.¿ THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO D8. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING THIS DUODENOVIDEOSCOPE, THE ELEVATOR WAS ALMOST IMPOSSIBLE TO USE FROM THE BEGINNING OF THE CASE. IT FELT LIKE IT WAS GRINDING AT THE DIALS AND DID NOT LOOSEN UP WITH A COUPLE OF DROPS OF MINERAL OIL. THE USER HAD TO USE TWO HANDS TO MANIPULATE THE ELEVATOR. IT MADE IT VERY DIFFICULT AND PROLONGED CASE. THE PROCEDURE WAS PROLONGED FOR ONE HOUR. MULTIPLE INADVERTENT PANCREATIC DUCT CANNULATION MAY HAVE OCCURRED AS A RESULT OF THE ISSUE, AS REPORTED BY THE PHYSICIAN. THE PATIENT HAD VERY HIGH LIPASE POST PROCEDURE WITH BRIEF PERIOD OF SELF-RESOLVED PAIN. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED PROBLEM. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. OLYMPUS WAS FURTHER INFORMED THAT THE PATIENT IS LESS THAN 1 YEAR OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628412 PJF-160 RENTAL (DMY) DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. PJF-160 04953170433498

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Unknown