BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ROTICULATOR 30-V3

    MDR report key: 174842 · Received June 25, 1998

    Report

    Report Number
    2647580-1998-00854
    Event Type
    Malfunction
    Date Received
    June 25, 1998
    Date of Event
    May 26, 1998
    Report Date
    May 27, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    1/25/1999- SUPPLEMENTAL REPORT SENT TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A PNEUMONECTOMY PROCEDURE. REPORTEDLY, THE STAPLES WERE MISSING. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ROTICULATOR 30-V3 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP NA P6F56

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN