BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1993914 · Received January 13, 2011

    Report

    Report Number
    1518293-2011-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER'S INVESTIGATION FOUND THE GENERATOR INTERFACE CONNECTOR TO THE IMAGING COMPUTER WAS LOOSE. FSE RESEATED AND TIGHTENED CONNECTION AND THEN VERIFIED PROPER OPERATION ACCORDING TO THE HUT SERVICE MANUAL. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS DURING RETROGRADE CYSTOGRAM PROCEDURE, SYSTEM FAILED. THE PHYSICIAN ABORTED THE PROCEDURE AT THAT TIME. CUSTOMER REPORTS THEY ARE NOT AWARE OF ANY INJURY AT THIS POINT OTHER THAN ABORTED PROCEDURE. CUSTOMER PROVIDES NO PATIENT OR PHYSICIAN INFORMATION FOR POSSIBLE FOLLOW UP. CUSTOMER REPORTS THE PATIENT PROCEDURE WAS NOT RESCHEDULED WITH THEIR FACILITY, BUT MAY HAVE BEEN PERFORMED AT ANOTHER FACILITY.

    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