BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO STITCH 10MM

    MDR report key: 96595 · Received June 4, 1997

    Report

    Report Number
    1219161-1997-00626
    Event Type
    Malfunction
    Date Received
    June 4, 1997
    Date of Event
    May 7, 1997
    Report Date
    May 8, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC NISSEN PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER DEVICE WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO STITCH 10MM DISPOSABLE SURGICAL INSTRUMENT GCJ UNITED STATES SURGICAL CORP. NA U4L11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN