BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 12842858 · Received November 19, 2021

    Report

    Report Number
    8010047-2021-14817
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 27, 2021
    Report Date
    April 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170382635
    PMA / PMN Number
    K950166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC FOUND THAT NOT ONLY THE CUTTING WIRE WAS BROKEN BUT ALSO THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED. HOWEVER, 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A CORRECTION TO G2. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE CONFIRMATION RESULT AND THE INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE BROKEN CUTTING WIRE MIGHT BE THE FOLLOWING: 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. 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 RAISED. 2. 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. 3. 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. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿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. ¿ 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.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A BIOMEDICAL ENGINEER THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN OFF ON THE FIRST ACTIVATION. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. OMSC FOUND THAT NOT ONLY THE CUTTING WIRE WAS BROKEN BUT ALSO 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
    1742672 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V411M-0725 17K 04953170382635

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown