BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SUTURE PREMIUM MULTIFIRE TA 30-V3

    MDR report key: 84815 · Received April 15, 1997

    Report

    Report Number
    1219930-1997-00836
    Event Type
    Injury
    Date Received
    April 15, 1997
    Date of Event
    March 20, 1997
    Report Date
    March 20, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 APPROX. 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 APPROX. 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 AN INTERIOR RIGHT LOBECTOMY PROCEDURE, THE INSTRUMENT LOCKED AFTER FIRED ON PULMONARY VEIN. THE SURGEON RESECTED THE INSTRUMENT OFF. THE HOSP REPORTED THAT THE PT'S CURRENT STATUS WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM MULTIFIRE TA 30-V3 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP. NA N6M137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other