BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM MULTIFIRE TA 60-4.8

    MDR report key: 150531 · Received February 19, 1998

    Report

    Report Number
    1219930-1998-00181
    Event Type
    Malfunction
    Date Received
    February 19, 1998
    Report Date
    January 23, 1998
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE STAPLES WERE MISSING. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM MULTIFIRE TA 60-4.8 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORPORATION NA N4C223

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN