BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER

    MDR report key: 41670 · Received August 30, 1996

    Report

    Report Number
    1527736-1996-00074
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 7, 1996
    Report Date
    August 29, 1996
    Manufacturer
    NA
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D10-INFO NOT PROVIDED BY AFFILIATE. F1: SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. D5: H4-INFO NOT AVAILABLE G3: CONSUMER WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH. BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED REPORTED INCIDENT. IT COULD NOT BE ASCERTAINED AS TO WHERE OR WHEN STAPLES HAD BEEN FIRED. IT SHOULD BE NOTED THAT ADEQUATE INSPECTION AND CONTROL POINTS EXIST IN MFG LINE ALONG WITH A LASER VISION INSPECTION SYSTEM THAT DETECTS MISSING STAPLES AND EMPTY INSTRUMENTS. IT SHOULD BE NOTED THAT STRINGENT INSPECTION AND CONTROL POINTS EXIST IN MFG LINE ALONG WITH A LASER INSPECTION SYSTEM THAT DETECTS MISSING STAPLES AND EMPTY INSTRUMENTS. THE STAPLE LOADING PROCESS WAS REVIEWED AND DEMONSTRATED A VERY HIGH DEGREE OF RELIABILITY. ALL EMPLOYEES ASSOCIATED WITH ASSEMBLY OF THIS INSTRUMENT HAVE BEEN INFORMED OF THIS REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. SURGEON APPLIED THE STAPLER TO CREATE A RECTAL STUMP. UPON REMOVAL THERE WERE NO STAPLES NOTICED. THE ANASTOMOSIS WAS COMPLETED WITH HAND SUTURE. THE EXCISION WAS BETWEEN THE STAPLER (RECTAL END) AND THE CLAMP (SPECIMEN END). THERE WAS NO CONSEQUENCE TO THE PT. 8/26/96 DR STATED "THE SPECIMEN REPORT SHOWED UNFORMED STAPLES FOUND ON 1/3 OF THE STAPLE LINE WITH 2/3 OF STAPLE LINE MISSING FROM SPECIMEN. THERE DID NOT APPEAR TO BE ANY DIFFICULTY IN CLOSING THE INSTRUMENT BEFORE FIRING. THE STEPS OF CLOSURE OF THE STAPLER WERE OBSERVED BY FIRST CLOSING THE WHITE TRIGGER AND FOLLOWED BY THE BLACK TRIGGER TO FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER LINEAR STAPLER GAG NA NA J43A64

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other