BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM MULTIFIRE TA* 60-4.8

    MDR report key: 90530 · Received May 7, 1997

    Report

    Report Number
    1219930-1997-00990
    Event Type
    Malfunction
    Date Received
    May 7, 1997
    Date of Event
    April 1, 1997
    Report Date
    April 8, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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

    THE DEVICE WAS USED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT RELEASE FROM THE TISSUE AFTER FIRING. THE SURGEON REMOVED THE INSTRUMENT WITH MANIPULATION. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM MULTIFIRE TA* 60-4.8 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP. NA N6J30

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN