BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ROTICULATOR 55-4.8

    MDR report key: 260242 · Received January 26, 2000

    Report

    Report Number
    2647580-2000-00079
    Event Type
    Malfunction
    Date Received
    January 26, 2000
    Date of Event
    September 6, 1999
    Report Date
    December 30, 1999
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE 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 ROTICULATOR 55-4.8 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP NA P9D25

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN