BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM MULTIFIRE TA 30-V3

    MDR report key: 53614 · Received November 27, 1996

    Report

    Report Number
    1219930-1996-00714
    Event Type
    Malfunction
    Date Received
    November 27, 1996
    Date of Event
    October 16, 1996
    Report Date
    November 1, 1996
    Manufacturer
    UNITED STATES SURGICA CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SUBJECT DEVICE REVEALED THAT THE DISTAL END OF THE "#2 LATCHING ROD" LIFTED AND BECAME DISENGAGED FROM THE SUPPORT BLOCK, INTERMITTENTLY, DURING APPROXIMATION OF THE INSTRUMENT, THE LATCH CAM ADVANCED THE ROD SLIGHTLY FORWARD WHICH RESULTED IN BINDING OF THE ROD BETWEEN THE CAM BRIDGE AND THE SUPPORT OPENING UPON ACTIVATION OF THE APPROXIMATING BUTTON. AS CORRECTIVE ACTION, PROCESS MODIFICATIONS WERE IMPLEMENTED TO MECHANICALLY PREVENT THE ROD FROM LIFTING AND ELIMINATE FURTHER OCCURRENCE OF THIS CONDITION.

    Description of Event or Problem · 1

    DURING A PNEUMONECTOMY PROCEDURE, THE INSTRUMENT WAS DIFFICULT TO OPEN AFTER FIRING. THE SURGEON MANUALLY MANIPULATED THE DEVICE OFF TISSUE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM MULTIFIRE TA 30-V3 DISPOSABLE STAPLER GAG UNITED STATES SURGICA CORP. NA N6G189

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN