BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE RETRIEVAL BASKET

    MDR report key: 4092407 · Received September 5, 2014

    Report

    Report Number
    8010047-2014-00523
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 14, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT RETURNED TO OMSC YET. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE INTENDED USE OF THIS DEVICE IS NOT FOR CRUSHING CALCULUS BUT FOR RETRIEVING IT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE DOCTOR ATTEMPTED TO CRUSH A LARGE CALCULUS WITH THE SUBJECT DEVICE BUT THE DISTAL END OF THE TWO BASKET WIRES BROKE. THE BROKEN BASKET WIRES DIDN'T COME OFF TO THE PATIENT AND HE REMOVED THE DEVICE FROM THE PATIENT. AFTER THAT, HE CHOSE BML-V442QR-30 AND COULD CRUSH THE CALCULUS. THERE WAS NO REPORT OF THE PATIENT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545756 SINGLE USE RETRIEVAL BASKET RETRIEVAL BASKET EOQ OLYMPUS MEDICAL SYSTEM CORP. FG-V432P 36K

    Patients

    Seq Age Sex Outcome Treatment
    1