BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 11662891 · Received April 14, 2021

    Report

    Report Number
    8010047-2021-04920
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Report Date
    April 14, 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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE CUTTING WIRE WAS BROKEN. THE BREAKING 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. NO OTHER ABNORMALITIES RELATED TO THE REPORTED PHENOMENON WERE DETECTED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE CUTTING WIRE BROKE DUE TO ANY OF THE FOLLOWING POSSIBLE CAUSES. HIGH FREQUENCY CURRENT WAS APPLIED BETWEEN THE CUTTING WIRE AND THE TISSUE AT THE POINT OF THE CONTACT. AS A RESULT, THE CURRENT DENSITY AT THE CONTACT AREA INCREASED, AND THE CUTTING WIRE BECAME INSTANTLY HOT. HIGH FREQUENCY CURRENT WAS APPLIED WHEN THE CUTTING WIRE AND THE TISSUE WERE BEING CLOSE TO EACH OTHER. AS A RESULT, AN ELECTRICAL DISCHARGE OCCURRED, AND THE CUTTING WIRE BECAME INSTANTLY HOT. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY, THREE DEVICES WERE USED IN COMBINATION WITH A SMALL INTESTINAL VIDEOSCOPE. THE CUTTING WIRES OF TWO DEVICES BROKE IN A ROW. THE INTENDED PROCEDURE WAS COMPLETED WITH THE THIRD DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562949 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V411M-0330 0YK

    Patients

    Seq Age Sex Outcome Treatment
    1