BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE SURGITIE

    MDR report key: 142163 · Received January 6, 1998

    Report

    Report Number
    1219161-1998-00009
    Event Type
    Malfunction
    Date Received
    January 6, 1998
    Date of Event
    December 7, 1997
    Report Date
    December 8, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    MFT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE SURGITIE Implant DISPOSABLE LIGATING LOOP MFT UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN