BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM MULTIFIRE TA 30-V3

    MDR report key: 63319 · Received January 3, 1997

    Report

    Report Number
    1219930-1997-00025
    Event Type
    Malfunction
    Date Received
    January 3, 1997
    Date of Event
    November 26, 1996
    Report Date
    December 5, 1996
    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

    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 BLOCK. THIS INTERMITTENT BINDING PREVENTED THE INSTRUMENT FROM 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. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM MULTIFIRE TA 30-V3 DISPOSABLE STAPLER GAG UNITED STATES SURGICAL CORP. NA N6D98

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN
    2