BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 12056046 · Received June 24, 2021

    Report

    Report Number
    8010047-2021-07921
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 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 REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO E1 AND H8. 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. BASED ON THE SIMILAR COMPLAINT INVESTIGATION RESULTS IN THE PAST, 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. THIS INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING INFORMATION: "-SINCE THE CUTTING WIRE IS VERY THIN, IT MAY BREAK OFF IN THE FOLLOWING CASES: THE DISTANCE BETWEEN THE PAPILLA OF VATER AND THE CUTTING WIRE IS VERY SHORT, THE OUTPUT IS TOO HIGH OR ACTIVATED WHILE THE CUTTING WIRE TOUCHES METAL PARTS OF THE ENDOSCOPE, OR THE CUTTING WIRE IS TIGHTENED TOO STRONG. WHEN THE CUTTING WIRE BREAKS OFF, ITS PROXIMAL END WILL BE RETRACTED TOWARD THE ENDOSCOPE IF THE SLIDER IS PULLED. IF THE SLIDER IS PUSHED, THE CUTTING WIRE WILL BE PUSHED OUT TOWARD THE PAPILLA OR MOVE SIDEWAYS. IF THE CUTTING WIRE BREAKS OFF, STOP THE OUTPUT IMMEDIATELY AND PULL THE SLIDER COMPLETELY TO RETRACT THE BROKEN CUTTING WIRE INTO THE TUBE. THEN WITHDRAW THE SPHINCTEROTOME FROM THE PAPILLA. OTHERWISE, PATIENT INJURY, SUCH AS PERFORATIONS, BLEEDING, OR LACERATIONS WITHIN THE BILIARY DUCT, AND/OR DAMAGE OF THE ENDOSCOPE COULD RESULT. -BE SURE THAT THE REAR END OF THE CUTTING WIRE IS EXTENDED FROM THE DISTAL END OF THE ENDOSCOPE. IN CASE THE CUTTING WIRE CONTACTS THE FORCEPS ELEVATOR, INSUFFICIENT OUTPUT OR UNINTENDED TISSUE INJURY MAY OCCUR. -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." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED.

    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 (B)(4).

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC, BECAUSE THE CUSTOMER DISCARDED THE SUBJECT DEVICE. THEREFORE, THE CONDITION OF THE DEVICE COULD NOT BE CONFIRMED. THIS EVENT HAS ALREADY OCCURRED IN THE PAST. BASED ON THE RESULT OF A PREVIOUS SIMILAR COMPLAINT INVESTIGATION, IT IS POSSIBLE TO PREDICT THE CAUSE OF THE REPORTED EVENT. THEREFORE, IT WAS DETERMINED THAT THE INVESTIGATION BY USING EQUIPMENTS OF SIMILAR STRUCTURE OR SIMILAR EQUIPMENTS WAS NOT NECESSARY. THE DEVICE WAS NOT RETURNED TO US FOR INVESTIGATION. HOWEVER, THE PICTURES OF THE PRODUCT WERE PROVIDED. THEREFORE, THE INVESTIGATION WAS IMPLEMENTED ON THE BASIS OF THE PICTURE. THE OTHER PICTURES REVEALED THAT THE COATED PORTION OF THE OTHER DEVICE WAS TORN. THE LOT NUMBER ¿0YV¿ INDICATED THAT THE DEVICE WAS MANUFACTURED IN NOVEMBER 2020. THE FOLLOWING DEVICE HISTORY RECORD WITH THE LOT NUMBER OF THE SUBJECT DEVICE WAS CONFIRMED. NO ABNORMALITIES FOUND FROM THE DEVICE HISTORY RECORD OF THE ITEMS WHICH RELATE TO THE REPORTED PHENOMENON. NONCONFORMING PRODUCT REPORT. ¦BREAKAGE OF CUTTING WIRE BASED ON THE SIMILAR COMPLAINT INVESTIGATION RESULTS IN THE PAST, IT IS POSSIBLE THAT AN ELECTRICAL DISCHARGE MIGHT HAVE OCCURRED IN ONE OF THESE FOLLOWING SITUATIONS. THIS CAUSED THE CUTTING WIRE TO BECOME HOT INSTANTLY. AS A RESULT, THE CUTTING WIRE BROKE. HIGH FREQUENCY CURRENT WAS CONDUCTED BETWEEN THE CUTTING WIRE AND THE TISSUE AT THE POINT OF CONTACT, OR HIGH FREQUENCY CURRENT WAS CONDUCTED WHEN THEY WERE BEING CLOSE TO EACH OTHER. HIGHT FREQUENCY CURRENT WAS CONDUCTED BETWEEN THE CUTTING WIRE AND THE DISTAL END OF THE ENDOSCOPE AT THE POINT OF CONTACT, OR HIGH FREQUENCY CURRENT WAS CONDUCTED WHEN THEY ARE BEING CLOSE TO EACH OTHER. DUE TO RAISING THE FORCEPS ELEVATOR, THE CUTTING WIRE AT THE TORN AREA OF THE COATED PORTION OF THE WIRE AND THE DISTAL END OF THE ENDOSCOPE CAME INTO CONTACT. UNDER THESE CIRCUMSTANCES, HIGH FREQUENCY CURRENT WAS CONDUCTED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    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. THE INTENDED PROCEDURE WAS COMPLETED WITH THE OTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. CUSTOMER REPORTED THAT THIS SAME EVENT ALSO HAPPENED DURING PREVIOUS WEEKS IN OTHER PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958426 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