BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 12098099 · Received July 1, 2021

    Report

    Report Number
    8010047-2021-08252
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Report Date
    May 3, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170380594
    PMA / PMN Number
    K950166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BECAUSE THE SUBJECT DEVICE WAS DISCARDED BY THE USER. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. ACCORDING TO THE PROVIDED PHOTO, IT WAS CONFIRMED THAT THE BREAKAGE OF THE CUTTING WIRE. THE CUTTING WIRE WAS BROKEN NEAR THE CENTER OR PROXIMAL END. (NEAR THE COATED PORTION) THE COATED PORTION OF THE DEVICE WAS TORN. THE LOT NUMBER ¿0YV¿ INDICATED THAT THE DEVICE WAS MANUFACTURED IN NOVEMBER 2020. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. IT IS POSSIBLE TO INFER THE CAUSE FROM THE RESULTS OF PAST SIMILAR INVESTIGATIONS, THEREFORE IT WAS DETERMINED THAT AN INVESTIGATION USING EQUIPMENT WITH SIMILAR STRUCTURE OR SIMILAR DEVICE IS UNNECESSARY. BASED ON THE PAST SIMILAR CASES, OMSC PRESUMES THAT THE EVENT OCCURRED DUE TO THE FOLLOWING OCCURRENCE MECHANISM. 1. THE CUTTING WIRE AT A TORN AREA OF THE COATED PORTION CAME INTO CONTACT WITH THE DISTAL END OF THE ENDOSCOPE WHILE THE FORCEPS ELEVATOR WAS RAISED. 2. THE OUTPUT WAS ACTIVATED IN STATE OF "1" DESCRIPTION, AND THE CUTTING WIRE BECAME HOT INSTANTLY. THIS CAUSED THE CUTTING WIRE TO BREAK. A LIKELY MECHANISM CAUSING THE TEAR OF THE COATED PORTION OF THE WIRE MIGHT BE THE FOLLOWING: 1. THE SLIDER WAS PUSHED MORE THAN NEEDED CAUSING THE CUTTING WIRE TO DEFLECT. 2. THE DEFLECTED COATED PORTION OF THE CUTTING WIRE AND THE METAL PART OF THE DISTAL END OF THE ENDOSCOPE CAME INTO CONTACT WHEN THE FORCEPS ELEVATOR WAS RAISED. 3. THE TUBE WAS MOVED BACK AND FORTH IN THE SITUATION OF DESCRIPTION "2", CAUSING THE METAL PART OF THE DISTAL END OF THE ENDOSCOPE TO SCRATCH THE COATED PORTION OF THE WIRE. AS A RESULT, THE COATED PORTION OF THE WIRE WAS RUPTURED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH A DEFINITIVE ROOT CAUSE OF THE PEELED COVER AND EXPOSED WIRE COULD NOT BE DETERMINED, LIKELY FACTORS CAUSING THE TEAR COULD HAVE BEEN THE FOLLOWING: 1 - THE SLIDER WAS PUSHED MORE THAN NEEDED CAUSING THE CUTTING WIRE TO DEFLECT. 2 - THE DEFLECTED COATED PORTION OF THE CUTTING WIRE AND THE METAL PART OF THE DISTAL END OF THE ENDOSCOPE CAME INTO CONTACT WHEN THE FORCEPS ELEVATOR WAS RAISED. 3 - THE TUBE WAS MOVED BACK AND FORTH IN THE SITUATION OF DESCRIPTION ¿2¿, CAUSING THE METAL PART OF THE DISTAL END OF THE ENDOSCOPE TO SCRATCH THE COATED PORTION OF THE WIRE. AS A RESULT, THE COATED PORTION OF THE WIRE WAS RUPTURED. THE CUSTOMER MAY BE ABLE TO REDUCE AND PREVENT OCCURRENCE OF THE EVENT BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU : WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, BE SURE THAT THE CUTTING WIRE IS PARALLEL TO THE TUBE. OTHERWISE, THE METAL PART OF THE FORCEPS ELEVATOR MAY CONTACT THE CUTTING WIRE AND PEEL OFF THE COATING MATERIAL. DO NOT ACTIVATE OUTPUT WHILE TISSUE IS IN CONTACT WITH THE TORN OR DAMAGED COATED PORTION OF THE DISTAL END. IF OUTPUT IS ACTIVATED WHILE TISSUE IS CONTACTING THE TORN OR DAMAGED COATED PORTION DUE TO INSERTION INTO OR WITHDRAWAL FROM AN ENDOSCOPE, LEAKAGE CURRENT, DECREASED OUTPUT, AND/OR THERMAL INJURY COULD RESULT. IF YOU FEEL THE CUTTING IS BLUNT, WITHDRAW THE DEVICE FROM THE SCOPE TO EXAMINE IF THERE IS ANY PEEL OFF AND TEAR AT THE COATING PORTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF 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 9614641.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OMSC FOR EVALUATION. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE COLANGIOPANCREATOGRAPHY USING THE SUBJECT DEVICE, JUST BEFORE PROCEEDING WITH THE SPHINCTEROTOMY, THE WIRE HAS BROKEN IN TWO PARTS AND THE PLASTIC COVER HAS DETACHED ON (B)(6). THE INTENDED PROCEDURE WAS COMPLETED WITH THE OTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ALSO, ON (B)(6) IT WAS INFORMED THAT THE CUSTOMER HAD PROBLEMS ALSO IN ANOTHER PREVIOUS PROCEDURES, BUT WE DID NOT KNOW THE DETAILS. ON THE (B)(6), WE COULD CONTACT WITH THE CUSTOMER. IT WAS INFORMED BY CUSTOMER THAT HE HAD SAME EVENTS NOT ONLY IN TWO PROCEDURE BEFORE (B)(6) EVENT BUT ALSO IN TWO MORE PROCEDURES AFTER (B)(6) EVENT. THIS IS THE REPORT REGARDING ONE OF TWO EVENTS BEFORE (B)(6) EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998976 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS AOMORI OLYMPUS CO., LTD. KD-V411M-0730 0YV 04953170380594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown