BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM SURGICLIP* M-11.5

    MDR report key: 92045 · Received May 15, 1997

    Report

    Report Number
    2647580-1997-00493
    Event Type
    Malfunction
    Date Received
    May 15, 1997
    Date of Event
    March 1, 1997
    Report Date
    April 17, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    6/23/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED PROCEDURE, THE TWO CLIPS WERE FIRED AT ONE TIME. THE SURGEON APPLIED ANOTHER DEVICE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM SURGICLIP* M-11.5 DISPOSABLE CLIP APPLIER GDO UNITED STATES SURGICAL CORP. NA P6H481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN