BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 12194769 · Received July 20, 2021

    Report

    Report Number
    8010047-2021-09099
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Report Date
    September 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170380594
    PMA / PMN Number
    K950166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. D9, H3 (NOT RETURNED TO MANUFACTURER: NO CHECK), H6 AND H10 IS CORRECTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR INVESTIGATION. THE CUTTING WIRE WAS BROKEN. INVESTIGATION WAS CARRIED OUT TO CONFIRM THE BROKEN PORTION. THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED. THE OUTER DIAMETER OF THE CUTTING WIRE WAS MEASURED. THE RESULT INDICATED NO ABNORMALITIES. THE LENGTH OF THE CUTTING WIRE AND THE COATED PORTION WAS MEASURED. THE DISTAL SIDE OF THE COATED PORTION WAS MISSING APPROXIMATELY 3.0 MM. OTHER ABNORMALITIES THAT COULD LEAD TO THE BREAKAGE OF THE CUTTING WIRE WERE NOT CONFIRMED. THE FOLLOWING DEVICE HISTORY RECORD WITH THE LOT NO.0YV 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 BASED ON THE INVESTIGATION RESULT AND SIMILAR COMPLAINT INVESTIGATION RESULTS IN THE PAST INDICATES THAT THE CAUSE OF THE CUTTING WIRE BREAKAGE MIGHT BE THE FOLLOWING REASONS. 1. THE CUTTING WIRE WAS OUT OF A TORN AREA OF THE COATED PORTION WHILE THE FORCEPS ELEVATOR OF THE ENDOSCOPE WAS BEING UP. AS A RESULT, THE CUTTING WIRE HAD CONTACT WITH THE DISTAL END OF THE ENDOSCOPE. 2. IN THE STATE OF BEING ¿1¿, THE ELECTRIC CONDUCTION WAS ACTIVATED. THE TEMPERATURE OF THE CUTTING WIRE INSTANTLY BECAME VERY HIGH AT THE CONTACT POINT. THIS CAUSED THE CUTTING WIRE TO BREAK. IT HAS BEEN CONFIRMED THAT THE TEAR OF THE COATED PORTION OF THE CUTTING WIRE COULD DUPLICATE BY THE FOLLOWING MECHANISM. 1. THE FORCEPS ELEVATOR OF THE ENDOSCOPE WAS BEING UP. 2. WHEN THE CUTTING WIRE DEFLECTS, THE COATED PORTION OF THE CUTTING WIRE AND THE METAL PART OF THE DISTAL END OF THE ENDOSCOPE HAD CONTACT WITH EACH OTHER. 3. IN THE STATE OF BEING ¿2¿, THE CUTTING WIRE MOVED BACK AND FORTH. THIS CAUSED THE COATED PORTION OF THE CUTTING WIRE TO TEAR. THE SLIDER WAS PUSHED MORE THAN NEEDED. THIS CAUSED THE CUTTING WIRE TO DEFLECT. IT CAN BE INFERRED THAT SOME KIND OF FORCE MIGHT HAVE APPLIED TO THE COATED PORTION OF THE CUTTING WIRE WHEN THE DEVICE WAS WITHDRAWN FROM ENDOSCOPE AFTER THE COATED PORTION O D THE CUTTING WIRE HAS TORN. THIS MIGHT HAVE CAUSED THE COATED PORTION OF THE CUTTING WIRE TO DETACH FROM THE CUTTING WIRE. AS A RESULT, THE COATED PORTION WAS PARTIALLY MISSING. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR INVESTIGATION. 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 EQUIPMENT OF SIMILAR STRUCTURE OR SIMILAR EQUIPMENT 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 ATTACHED PICTURE OF THE DEVICE REVEALED THE BREAKAGE OF THE CUTTING WIRE. THE CUTTING WIRE WAS BROKEN NEAR THE CENTER OR PROXIMAL END. (NEAR THE COATED PORTION) THE OTHER PICTURES REVEALED THAT THE COATED PORTION OF THE DEVICE WAS TORN. HOWEVER, IT DID NOT REVEAL WHETHER THESE DEVICES WERE SAME. THE LOT NUMBER ¿0YV¿ INDICATED THAT THE DEVICE WAS MANUFACTURED IN NOVEMBER 2020. THE EVENT DESCRIPTION POSSIBLY INDICATES THAT THE DETACHMENT OF THE COATED PORTION AND THE BREAKAGE OF THE CUTTING WIRE OCCURRED IN ONE DEVICE. BASED ON THE SIMILAR COMPLAINT INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE BROKEN CUTTING WIRE MIGHT BE THE FOLLOWING. 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. THE OUTPUT WAS ACTIVATED IN STATE OF ¿1¿ DESCRIPTION, AND THE CUTTING WIRE BECAME HOT INSTANTLY. THIS CAUSED THE CUTTING WIRE TO BREAK. 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 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 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 AFTER 2ND JUNE¿S EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095082 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V411M-0730 0YV 04953170380594

    Patients

    Seq Age Sex Outcome Treatment
    1