BEUDAMED
    FDA Adverse Event Other Summary report: N

    USSC-AUTOSUTURE MULTIFIRE HERNIA STAPLER

    MDR report key: 12095 · Received February 10, 1994

    Report

    Report Number
    12095
    Event Type
    Other
    Date Received
    February 10, 1994
    Date of Event
    July 2, 1993
    Report Date
    July 15, 1993
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SEVEN DAYS POST BILATERAL INGUINAL HERNIA REPAIRS THE PT HAS A RECURRENT HERNIA ON LEFT AND POSSIBLE RECURRENT HERNIA ON RIGHT. PHYSICIAN WILL BE EXAMINING PT ON 7/16/93. FAILURE PROBABLY DUE TO STAPLE DESIGN REGARDING LENGTH. HOWEVER, OTHER PROBLEMS CANNOT BE RULED OUT WITH DEVICE SINCE AN INSTRUMENT USED JUST PRIOR TO THIS, WHERE THE HANDLE BROKE AND IT COULD NOT BE USED. REPEAT SURGERY WILL BE NEEDED IF MARLEX MES DOES NOT "SCAR" INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC-AUTOSUTURE MULTIFIRE HERNIA STAPLER Implant AUTOSUTURE GAG UNITED STATES SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 * Other