BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTRE MINISITE 2MM CUP GRASPER

    MDR report key: 250062 · Received November 10, 1999

    Report

    Report Number
    1219161-1999-00999
    Event Type
    Malfunction
    Date Received
    November 10, 1999
    Date of Event
    September 26, 1999
    Report Date
    October 27, 1999
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    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 HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTRE MINISITE 2MM CUP GRASPER REUSABLE LAPAROSCOPIC INSTRUMENT GCJ UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN