BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 19688726 · Received July 8, 2024

    Report

    Report Number
    9614641-2024-01388
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 30, 2024
    Report Date
    December 23, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LQC
    UDI-DI
    04953170218422
    PMA / PMN Number
    CLASS2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF DEVICE HISTORY RECORD AND HISTORICAL COMPLAINTS ANALYSIS WAS CONDUCTED AND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE WERE IDENTIFIED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THERE WAS WHAT LOOKED LIKE A PIECE OF TISSUE ATTACHED TO THE GUIDEWIRE TIP. THE GUIDEWIRE TIP WAS TORN AND FRACTURE SHAPE SUGGESTS A BRITTLE FRACTURE. INSPECTION OF THE FRACTURE SURFACE OF THE LOW-STRENGTH GUIDE WIRE DISTAL END REVEALED LAYERED RESIN SOLIDIFICATION AND THE PRESENCE OF WELDS. BRITTLE FRACTURES ORIGINATED AT THE WELDS, MAKING THE GUIDE WIRE DISTAL END MORE SUSCEPTIBLE TO TEARING. THIS SUGGESTS A MOLDING DEFECT IN THE GUIDE WIRE DISTAL END, INDICATING THAT IT WAS NOT MOLDED UNDER OPTIMAL PROCESSING CONDITIONS. THE SUGGESTED EVENT IS DETECTABLE AND PREVENTABLE BY HANDLING THE SCOPE IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR USE: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT THE GUIDEWIRE TIP WAS TORN ON THE LITHOTRIPTOR. THIS OCCURRED DURING A THERAPEUTIC ENDOSCOPIC STONE REMOVAL PROCEDURE. THIS WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF A DELAY OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193372 SINGLE USE MECHANICAL LITHOTRIPTOR V SINGLE USE MECHANICAL LITHOTRIPTOR LQC AOMORI OLYMPUS CO., LTD. BML-V442QR-30 3ZK 04953170218422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown