BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 528589 · Received May 21, 2004

    Report

    Report Number
    MW1032154
    Event Type
    Malfunction
    Date Received
    May 21, 2004
    Date of Event
    January 7, 2004
    Report Date
    May 17, 2004
    Manufacturer
    UNITED STATES SURGICAL CORP DIV
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HERE FOR LEFT HAND ASSISTED LAP RADIAL NEPHRECTOMY. AUTOSUTURE ENDOGIA UNIVERSAL ROTICULATOR 30-2.5 #030451 STAPLE RELOAD "DID NOT FIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDOGIA KOG UNITED STATES SURGICAL CORP DIV ENDOGIA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *