BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN NEEDLE KNIFE V

    MDR report key: 12581903 · Received October 6, 2021

    Report

    Report Number
    8010047-2021-12776
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 13, 2021
    Report Date
    April 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170244124
    PMA / PMN Number
    K955247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ·ALWAYS OPERATE THE ELECTROSURGICAL UNIT AT THE MINIMUM OUTPUT LEVEL AND FOR THE MINIMUM TIME NECESSARY TO SUCCESSFULLY COMPLETE THE PROCEDURES. EXCESSIVE OUTPUT LEVEL AND TIME MAY RESULT IN PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. ·WHEN APPLYING OUTPUT, KEEP MOVING THE CUTTING KNIFE. WHEN THE KNIFE STOPS AND TOUCHES TISSUE AT A POINT, CONCENTRATED ELECTRIC CURRENT COULD CAUSE THE DISTAL TIP OF THE KNIFE TO DISSOLVE AND COME OFF IN THE BODY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION OF OMSC THE FOLLOWING WAS CONFIRMED, THE LOT NUMBER WAS 0YK WITH SUPPLEMENTARY INFORMATION NUMBER OF "12". THE BROKEN PORTION WAS SCORCHED AND MELTED. THE CUTTING KNIFE OF THE DEVICE SIDE WAS BROKEN AT THE DISTAL END OF THE TUBE. THE BROKEN PORTION OF THE CUTTING KNIFE WAS SCORCHED AND MELTED. THE OUTER DIAMETER OF THE CUTTING KNIFE WAS MEASURED. THE RESULT INDICATED NO ABNORMALITIES. THE LENGTH OF THE COATED PORTION OF THE CUTTING KNIFE, AND THE CUTTING KNIFE ITSELF PRESENTED NO ABNORMALITIES. THERE WERE NO MISSING PARTS IN THE SUBJECT DEVICE. OTHER ABNORMALITIES THAT COULD LEAD TO THE BREAKAGE OF THE CUTTING KNIFE WERE NOT CONFIRMED. NO ABNORMALITIES WERE DETECTED IN THE DEVICE HISTORY RECORD WITH THE LOT NUMBER FOR THE FOLLOWING INSPECTION ITEMS WHICH RELATED TO THE REPORTED PHENOMENON. APPEARANCE OF CUTTING WIRE. LENGTH OF CUTTING WIRE PARTS. OPERATION OF CUTTING WIRE. BASED ON THE CONFIRMATION RESULT OF THE SUBJECT DEVICE, IT IS POSSIBLE THAT THE FOLLOWING FACTORS MIGHT HAVE CAUSED THE ELECTRICAL DISCHARGE THAT LED TO THE BREAKAGE OF THE CUTTING KNIFE. THE CUTTING KNIFE HAD NOT BEEN KEPT ON MOVING. THE LENGTH OF CONTACT BETWEEN THE TISSUE AND THE CUTTING KNIFE WAS SHORT. THE OUTPUT ACTIVATION TIME WAS LONG. THE SETTING VALUE FOR THE OUTPUT ACTIVATION WAS HIGH. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE CUTTING KNIFE BROKE AND FELL OFF DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE USER FACILITY STATES THAT THE NON-OLYMPUS GENERATOR VIO300 SETTING WAS THE SAME AS USUAL AND NOT CHANGED. THE USER FACILITY RECOVERED THE DROPPED PART DURING THE PROCEDURE, THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479824 SINGLE USE 3-LUMEN NEEDLE KNIFE V SINGLE USE 3-LUMEN NEEDLE KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V441M 0YK 04953170244124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown