BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM PLUS CEEA 31MM

    MDR report key: 165200 · Received April 28, 1998

    Report

    Report Number
    1219161-1998-00783
    Event Type
    Malfunction
    Date Received
    April 28, 1998
    Date of Event
    March 24, 1998
    Report Date
    March 31, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    4/01/1999-SUPPLEMENTAL REPORT SENT TO FDA. ADDITIONAL INFO ENTERED IN D-9 (PRODUCT RETURN DATE). DEVICE EVAL INDICATED IN H-3 AND EVAL CODES ENTERED IN H-6.

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT MISFIRED. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM PLUS CEEA 31MM DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN