BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-655

    MDR report key: 23617209 · Received November 21, 2025

    Report

    Report Number
    9614641-2025-01934
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 29, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    PMA / PMN Number
    K171158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE ADDITIONAL INFORMATION RECEIVED AND CORRECTION FOR PREVIOUSLY SUBMITTED REPORT. CORRECTION H6 REMOVED HEALTH EFFECT IMPACT CODE F26. CORRECTION H6 REMOVED MEDICAL DEVICE PROBLEM CODE A040101 AND A150101 / ADDED A0401 AND A040610. CORRECTION H6 INVESTIGATION CONCLUSION REMOVED D12. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE, LIKELY DUE TO STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. HOWEVER, THE MOST PROBABLE CAUSE COULD BE THE USE OF A HIGH-FREQUENCY PROCESSING INSTRUMENT WITHOUT SUFFICIENT DISTANCE FROM THE TIP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE ELECTROSURGICAL KNIFE TIP WAS MELTED AND LOST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346770 SINGLE USE ELECTROSURGICAL KNIFE KD-655 SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-655Q 56K04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown