BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)

    MDR report key: 20101411 · Received August 29, 2024

    Report

    Report Number
    9614641-2024-01745
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 30, 2024
    Report Date
    January 30, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    PMA / PMN Number
    K141991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN ABOUT 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUBJECT DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE UNAVAILABLE FOR AN EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATES: ¿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.¿ THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO E2 AND E3 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000395. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUTTING WIRE BROKE INSIDE OF THE PATIENT DURING AN UNSPECIFIED PROCEDURE. THE PHYSICIAN WAS ABLE TO RETRIEVE IT AND PULL IT OUT OF THE PATIENT WITHOUT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355880 SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED) SINGLE USE PRELOADED SPHINCTEROTOME KNS AOMORI OLYMPUS CO., LTD. KD-VC631Q-07301S 42V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention