BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2182226 · Received July 12, 2011

    Report

    Report Number
    1518293-2011-00122
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON 06/30: CUSTOMER REPORTS THAT A PATIENT WAS HAVING A STONE REMOVAL PROCEDURE. PHYSICIANS DETERMINED THE IMAGE QUALITY OF THE SYSTEM DID NOT PROVIDE THEM WITH ADEQUATE IMAGING TO PERFORM THE PROCEDURE AND CANCELLED THE PROCEDURE. PHYSICIAN PERFORMED THE PATIENT PROCEDURE AT A LATER TIME AT ANOTHER HEALTHCARE FACILITY. NO REPORTED INJURY. CUSTOMER WOULD NOT PROVIDE FURTHER PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-REVERSE UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK