BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER

    MDR report key: 82221 · Received February 27, 1997

    Report

    Report Number
    1527736-1997-00081
    Event Type
    Malfunction
    Date Received
    February 27, 1997
    Report Date
    February 26, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LOW ANTERIOR RESECTION THE AX55G MISFIRED WHILE TRANSECTING THE RECTAL STUMP. THERE ARE NO FURTHER DETAILS. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 2/4/97 1405 SPOKE WITH CONTACT PERSON, AND HE STATED HE WOULD ATTEMPT TO GATHER ADD'L INFO. 2/4/97 1415 RETURNED THE CALL AND SAID DURING THE CASE THE SURGICAL TECH NOTED THE STAPLES WERE PROTRUDING FROM THE DEVICE BEFORE IT HAD BEEN FIRED. THE TECH ASKED THE SURGEON IF HE HAD SQUEEZED THE DEVICE AND HE HAD NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER LINEAR STAPLELRS GAG EES-CINCINNATI NA HA4614

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other