BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSONIC COAGULATING SHEARS

    MDR report key: 41983 · Received October 3, 1996

    Report

    Report Number
    1527736-1996-90002
    Event Type
    Malfunction
    Date Received
    October 3, 1996
    Date of Event
    September 3, 1996
    Report Date
    October 3, 1996
    Manufacturer
    ETHICON ENDO-SURGRY, INC.
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC BOWEL PROCEDURE. THE WHITE TISSUE PAD BROKE OFF AND LANDED IN THE PT. THERE WAS NO CONSEQUENCE TO THE PT. THE REP REPORTED THE PROCEDURE WAS LENGTHY. THERE WAS NOT A LOT OF MESENTERY IN THE JAWS OF THE DEVICE. TO FINISH THE CASE THE SURGEON USED A SECOND DEVICE AND WAS ABLE TO REMOVE THE TISSUE PAD LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSONIC COAGULATING SHEARS COAGULATING SHEARS KNS ETHICON ENDO-SURGRY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other