BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE* SURGIPORT* 10MM

    MDR report key: 92928 · Received May 21, 1997

    Report

    Report Number
    2647580-1997-00528
    Event Type
    Malfunction
    Date Received
    May 21, 1997
    Date of Event
    April 23, 1997
    Report Date
    April 23, 1997
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PROCEDURE, THE SHIELD DID NOT RETRACT. THE SURGEON APPLIED ANOTHER ANOTHER DEVICE WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE* SURGIPORT* 10MM DISPOSABLE SURGICAL TROCAR GCJ UNITED STATES SURGICAL CORPORATION NA P4H268

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN