BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 18711338 · Received February 15, 2024

    Report

    Report Number
    9614641-2024-00384
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 29, 2024
    Report Date
    March 11, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LQC
    UDI-DI
    04953170218422
    PMA / PMN Number
    CLASS2-EXMPT
    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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE TORN GUIDEWIRE TIP WAS LIKELY CAUSE BY THE USER INSERTING THE TIP AND GUIDE WIRE INTO THE ENDOSCOPE AT A SHARP ANGLE AND FORCE WAS APPLIED. HOWEVER, SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE ISSUE CAN BE PREVENTED BY FOLLOWING THE (B)(6) INSTRUCTION MANUAL WHICH PROVIDES THE FOLLOWING WARNING: ¿ WHEN USING THE GUIDE WIRE, INSERT THE INSTRUMENT WITH ITS DISTAL TIP IN PARALLEL WITH THE GUIDE WIRE WHILE HOLDING THE DISTAL TIP AS SHOWN IN FIGURE 4.20. BE CAREFUL NOT TO FORCIBLY INSERT THE INSTRUMENT WITH A SHARP ANGLE BETWEEN THE DISTAL TIP AND THE GUIDE WIRE AS SHOWN IN FIGURE 4.21. THIS MAY DAMAGE THE DISTAL TIP. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND THE EVALUATION FOUND THE GUIDEWIRE TIP WAS TORN AND THE MORPHOLOGY OF THE TEAR WAS BRITTLE FRACTURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO MFR: 00382 (2/2).

    Description of Event or Problem · 0

    IT WAS REPORTED, PART OF THE GUIDEWIRE TIP OF THE SINGLE USE MECHANICAL LITHOTRIPTOR, WHERE THE GUIDEWIRE WAS INSERTED, WAS TORN WHICH MADE IT DIFFICULT TO INSERT IT. THE SECOND ONE WAS USED AS IS AND COMPLETED THE PROCEDURE. THE SAME PROBLEM OCCURRED TWO TIMES IN A ROW. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE AND IT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030031 SINGLE USE MECHANICAL LITHOTRIPTOR V SINGLE USE MECHANICAL LITHOTRIPTOR LQC AOMORI OLYMPUS CO., LTD. BML-V442QR-30 23K 04953170218422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown