BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MINISITE ENDO GRASP 2MM

    MDR report key: 249974 · Received November 10, 1999

    Report

    Report Number
    1219161-1999-01000
    Event Type
    Malfunction
    Date Received
    November 10, 1999
    Date of Event
    October 9, 1999
    Report Date
    October 27, 1999
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOS HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MINISITE ENDO GRASP 2MM REUSABLE LAPAROSCOPIC INSTRUMENT GAG UNITED STATES SURGICAL CORP. 171326 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN