BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 12451285 · Received September 9, 2021

    Report

    Report Number
    8010047-2021-11528
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 27, 2021
    Report Date
    September 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    PMA / PMN Number
    K950166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION AND 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 COATED PORTION OF THE CUTTING WIRE, AND THE CUTTING WIRE ITSELF PRESENTED NO ABNORMALITIES. THERE WERE NO MISSING PARTS IN THE SUBJECT DEVICE. OTHER ABNORMALITIES THAT COULD LEAD TO THE BREAKAGE OF THE CUTTING WIRE WERE NOT CONFIRMED. THE FOLLOWING INFORMATION WAS PROVIDED FROM THE INITIATOR. WHICH ELECTROSURGICAL UNIT WAS BEING USED FOR THE PROCEDURE? ;VIO3 WHAT WAS THE SETTING VALUE FOR THE CUT MODE AND THE COAGULATION MODE? ; >ENDO CUT ENDOCUTI 1-3-3 SOFTCOAG 8.5 AUTOCUT 4.0 SOFTCOAG 8.5 WHICH MODE WAS BEING USED WHEN THE EVENT OCCURRED? (CUT, BLEND OR COAGULATION) ;CUT WHAT IS THE AVERAGE ACTIVATION TIME FOR THE CUT MODE OR THE COAGULATION MODE? HOW LONG IS THE MAXIMUM ACTIVATION TIME? ;THE ENERGIZATION TIME PER ONE TIME WAS 0.1-0.2 SECONDS. NO ABNORMALITIES WERE DETECTED IN THE DEVICE HISTORY RECORD WITH THE LOT NUMBER FOR THE FOLLOWING INSPECTION ITEMS WHICH RELATED TO THE REPORTED PHENOMENON. LENGTH OF CUTTING WIRE LENGTH OF COATED PORTION OPERATION OF CUTTING WIRE BASED ON THE CONFIRMATION RESULT AND THE 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. IT HAS BEEN CONFIRMED THAT THE TEAR OF THE COATED PORTION OF THE CUTTING WIRE COULD DUPLICATE BY THE FOLLOWING MECHANISM. THE FORCEPS ELEVATOR OF THE ENDOSCOPE WAS RAISED. WHEN THE CUTTING WIRE DEFLECTS, THE COATED PORTION OF THE CUTTING WIRE AND THE METAL PART OF THE DISTAL END OF THE ENDOSCOPE COME INTO CONTACT. IN STATE OF DESCRIPTION ¿2¿, THE CUTTING WIRE WAS 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. AVOIDING THE ABOVE SITUATIONS WILL PREVENT THE CUTTING WIRE FROM BREAKING. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE BIOMEDICAL ENGINEER THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY USING THE SUBJECT DEVICE WITH VIO3 INCISION MODE, THE CUTTING WIRE WAS BROKEN OFF. IT WAS NOT FOUND WHETHER THE DEVICE WAS ACTIVATING OR NOT DURING THE BREAKAGE OF CUTTING WIRE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION AND INVESTIGATION. OMSC FOUND THAT THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346782 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V431M-0720 16K

    Patients

    Seq Age Sex Outcome Treatment
    1