BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE SI

    MDR report key: 3032166 · Received March 6, 2013

    Report

    Report Number
    1213643-2013-00082
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 7, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO HAVE THE SAMPLE RETURNED FOR EVALUATION. TO DATE, THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE MFG RECORDS FOR THE REPORTED PRODUCT CODE AND LOT NUMBER REVEALED THAT THERE WERE NO DISCREPANCIES DURING THE MANUFACTURE AND THERE WAS NO EVIDENCE OF ANY MFG RELATED ISSUE WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AT THIS TIME, NO CONCLUSION CAN BE MADE. SEE MDR 1213643-2013-00080 FOR INFO RELATED TO THE FIRST SIMPULSE USED.

    Description of Event or Problem · 1

    INFO AS REPORTED TO DAVOL: IT WAS REPORTED THAT DURING AN ARTHROSCOPIC CASE, A SIMPULSE SOLO IRRIGATOR WAS BEING USED ON THE PT WHEN THE TIP DETACHED. IT DID NOT FALL INTO PT. A SECOND IRRIGATOR WAS THEN TESTED, BEFORE USE ON THE PT, WHEN THE TIP FELL OFF. THE CASE WAS COMPLETED WITH A DIFFERENT PRODUCT WITH NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96521 SIMPULSE SI FQH DAVOL INC., SUB. C.R. BARD, INC. NA JUWLF030

    Patients

    Seq Age Sex Outcome Treatment
    1