BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 21823952 · Received April 11, 2025

    Report

    Report Number
    9614641-2025-00503
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 11, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    MND
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED; IT IS LIKELY THAT THE REPORTED EVENT MIGHT HAVE OCCURRED THROUGH THE FOLLOWING MECHANISM. 1) UNNECESSARY PART OF THE LOOP WAS CUT USING THE LOOP CUTTER. 2) A PIECE OF A CUT-OFF LOOP WAS SUCTIONED INTO THE ENDOSCOPE. 3) THERE WAS AN INAPPROPRIATE PROCEDURE WHEN CLEANING THE ENDOSCOPE AFTER USE, AND THE LOOP REMAINED IN THE CHANNEL OF THE ENDOSCOPE. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE EVENT IS DETECTABLE/PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU: DRAWING NUMBER AND REVISION NUMBER OF IFU: GK8332_04 THE OPERATOR OF THIS INSTRUMENT MUST BE A PHYSICIAN OR MEDICAL PERSONNEL UNDER THE SUPERVISION OF A PHYSICIAN AND MUST HAVE RECEIVED SUFFICIENT TRAINING IN CLINICAL ENDOSCOPIC TECHNIQUE. THIS MANUAL, THEREFORE, DOES NOT EXPLAIN OR DISCUSS CLINICAL ENDOSCOPIC PROCEDURES. ANY UNNECESSARY PARTS OF THE LOOP CAN BE CUT USING THE OLYMPUS LOOP CUTTER (FS-5L/Q/U-1). IT CAN BE COLLECTED USING GRASPING FORCEPS. 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

    IT WAS REPORTED THAT DURING A THERAPEUTIC COLON POLYPECTOMY PROCEDURE, WHILE CLEANING THE COLONOVIDIOSCOPE(CF-XZ1200I) IN THE SINK, A LOOP FROM A PREVIOUSLY USED INDWELL SNARE SINGLE USE LIGATING DEVICE (HX-400U-30) APPEARED. TWO LOOPS WERE CONFIRMED, THE FIRST WAS FOUND IN THE BIOPSY CHANNEL AT THE DISTAL END OF THE SCOPE, AND THE SECOND WAS FOUND IN THE SUCTION CHANNEL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425753 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE MND AOMORI OLYMPUS CO., LTD. HX-400U-30

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CF-XZ1200I.