BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI VISITEC

    MDR report key: 2469939 · Received February 20, 2012

    Report

    Report Number
    1211998-2012-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    January 17, 2012
    Report Date
    February 17, 2012
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(4). A REPORT RECEIVED FROM A DISTRIBUTOR ON (B)(4) 2012 CLAIMED THE IRRIGATING CYSTOTOME BROKE DURING A PROCEDURE BUT NO PATIENT INJURY OCCURRED. WE RECEIVED THE AFFECTED UNIT FROM THE DISTRIBUTOR ON (B)(4). A VOICE MESSAGE WAS LEFT WITH THE DISTRIBUTOR CONTACT TO ATTEMPT TO GAIN MORE INFORMATION AROUND THIS COMPLAINT. NO RESPONSE WAS RECEIVE AT THE TIME OF THIS REPORT. WE WILL CONTINUE WITH REPEATED ATTEMPTS. WE WILL CONTINUE TO INVESTIGATE THIS FAILURE TO IDENTIFY A ROOT CAUSE FOR THE BREAKAGE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED. ALL TESTS AND INSPECTION WERE ACCEPTABLE. A SEARCH FOR SIMILAR REPORTS IN OUR COMPLAINT SYSTEM DID NOT UNCOVER ANY OTHER OCCURRENCE FOR CANNULA OR CYSTOTOME BREAKAGE. A QUANTITY OF (B)(4) UNITS OF CATALOG 581610 WERE MANUFACTURED SINCE 10/2010. WE WILL CONTINUE TO INVESTIGATE AND PROVIDE A FOLLOW-UP REPORT ON OR ABOUT (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BVI VISITEC IRRIGATING CYSTOTOME .50 X 16MM HMX BEAVER-VISITEC INTERNATIONAL NA 3007469

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other