BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARPETRA

    MDR report key: 11752269 · Received April 29, 2021

    Report

    Report Number
    MW5101087
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 28, 2021
    Manufacturer
    WELL LEAD MEDICAL CO., LTD.
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLEARPETRA DEVICE IS SUPPOSED TO ALLOW THE SURGEON TO NOT NEED TO USE A BASKET TO RETRIEVE STONE PARTICLES AFTER LASERING. THE PRODUCT WAS NOT SUCTIONING THE STONES APPROPRIATELY AND REQUIRED THE SURGEON TO REVERT TO USING A BASKET. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646193 CLEARPETRA ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED WELL LEAD MEDICAL CO., LTD. 90111246 2005020531CE

    Patients

    Seq Age Sex Outcome Treatment
    1