BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE DUODENOVIDEOSCOPE

    MDR report key: 14407326 · Received May 16, 2022

    Report

    Report Number
    8010047-2022-08301
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 18, 2022
    Report Date
    May 9, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AN INTERVIEW WAS CONDUCTED BY OLYMPUS, WITH THE FACILITY AS PART OF THE ROOT CAUSE INVESTIGATION PER CAPA-200735. IT WAS CONFIRMED, BY THE FACILITY, THAT THERE HAS BEEN NO CHANGE IN THE STORAGE METHOD OF THE DISTAL COVERS, SINCE EXPERIENCING THE DETACHMENT ISSUE. THE DISTAL COVER STERILIZATION PACKS ARE REMOVED FROM THE PRODUCT CARTON AND STORED IN A DRAWER. THE FACILITY DID NOT PROVIDE AN ANSWER TO WHETHER, THE CHEMICALS USED, DURING THE REPORTED INCIDENT (DETACHMENT OF THE DISTAL COVER) ARE KNOWN. HOWEVER, THEY STATED, THAT THEY TYPICALLY APPLY SULPRO JELLY LUBRICANT TO THE DISTAL END OF THE ENDOSCOPE. NO DEFOGGER IS USED. GASCON (ABOUT 10CC GASCON DILUTED IN ABOUT 300CC WATER) IS ADMINISTERED DIRECTLY INTO THE BODY THROUGH THE FORCEPS CHANNEL, DURING ENDOSCOPE INSERTION AND SENT TO THE FORCEPS CHANNEL TO LUBRICATE. CONTRAST (UROGRAFIN) AND PHYSIOLOGICAL SALINE ARE ADMINISTERED THROUGH THE CANNULA, DURING THE ENDOSCOPE INSERTION. IF BLEEDING OCCURS, ADRENALINE (DILUTED WITH 20CC OF PHYSIOLOGICAL SALINE) IS ADMINISTERED. XYLOCAINE VISCUS IS ADMINISTERED ORALLY TO THE PATIENT BEFORE THE INSPECTION. ONLY TAP WATER (NO CHEMICALS) IS USED, DURING ENDOSCOPE PREPARATION AND PRE-USE INSPECTION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF EVALUATION AND 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. SCOPE FAILURE SUCH AS BURR, EDGE, OR LARGE DIMENSION WAS NOT CONFIRMED AROUND THE ASSEMBLY. IT WAS CHECKED IF A DETACHMENT OR TEAR COULD OCCUR BY PULLING OR TWISTING IN THE CONDITION THAT THE MAJ-2315 (SINGLE USE DISTAL TIP COVER) WAS ATTACHED; HOWEVER, THE DEFECT WAS NOT REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. SCOPE FAILURE WAS NOT FOUND. AS THE SUGGESTED EVENT WAS NOT REPRODUCED, THE FOLLOWING CAUSES WERE PRESUMABLE: THE MAJ-2315 WAS NOT PROPERLY ATTACHED. THERE WERE ALREADY ABNORMALITIES ON THE MAJ-2315 LIKE A TEAR WHEN IT WAS ATTACHED. IT IS SUGGESTED THAT THE USER FACILITY CHECK THE HANDLING STATUS OF THE DEVICE AS NEEDED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED, AFTER AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE PATIENT FELT SICK THE NIGHT OF THE PROCEDURE AND VOMITED THE DISTAL END COVER ALONG WITH EMESIS. THE PATIENT STATED THERE WAS A CRACK ON THE 'HAND SIDE' OF THE DISTAL END COVER. THE FACILITY REPORTED THE PROCEDURE WAS COMPLETED AND IT WAS NOT IDENTIFIED THE DISTAL END CAP WAS MISSING AT THE END OF THE PROCEDURE AND WAS INADVERTENTLY LEFT IN THE PATIENT. THERE ARE 2 REPORTS FOR THIS EVENT: (B)(6): TJF-Q290V, (B)(4). (B)(6): MAJ-2315. THIS REPORT IS 1 OF 2 FOR (B)(6): TJF-Q290V, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091518 EVIS LUCERA ELITE DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q290V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MAJ-2315, UNKNOWN LOT