BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE SOLO

    MDR report key: 3003664 · Received February 11, 2013

    Report

    Report Number
    1213643-2013-00049
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FQH
    PMA / PMN Number
    K942886
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED PRODUCT CODE AND LOT NUMBER REVEALED THAT THERE WERE NO DISCREPANCIES DURING MANUFACTURE AND THERE WAS NO EVIDENCE OF ANY MANUFACTURING RELATED ISSUE WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE SUBJECT PRODUCT IS IN THE PROCESS OF BEING EVALUATED. THEREFORE, NO CONCLUSION CAN BE DRAWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    INFORMATION REPORTED TO DAVOL: IT WAS REPORTED THAT WHILE IRRIGATING DURING A SURGERY THE PURPLE TIP OF THE SIMPULSE IRRIGATOR CAME OFF AND HAD TO BE RETRIEVED FROM THE FEMORAL CANAL. THE DEVICE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59216 SIMPULSE SOLO FQH DAVOL INC., SUB. C.R. BARD, INC. NA JUWJF469

    Patients

    Seq Age Sex Outcome Treatment
    1