BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPOSE ULC

    MDR report key: 365023 · Received December 10, 2001

    Report

    Report Number
    MW1023567
    Event Type
    Malfunction
    Date Received
    December 10, 2001
    Date of Event
    December 10, 2001
    Report Date
    December 10, 2001
    Manufacturer
    AMERICAN CYANAMID COMP US SURGICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY FOR THE REMOVAL OF A PELVIC/ABDOMINAL MASS, THE SKIN STAPLER COMPLETELY BROKE APART WHILE ON THE FIELD. THIRTY-FIVE STAPLES WERE SCATTERED. THIRTY-FOUR WERE RECOVERED. THE PT IS GOING FOR X-RAYS AND POSSIBLE MKI. SURGICAL TEAM IS CONFIDENT THE STAPLE WAS LOST IN THE ROOM. THE NEXT STAPLE GUN THEY OPENED HOWEVER HAD 3 ADD'L STAPLES (38 INSTEAD OF 35). LATER THAT DAY WITH A DIFFERENT PT - THE SAME BRAND AND TYPE OF STAPLER JAMMED DURING THE PROCEDURE AND WAS NOT ABLE TO BE USED. THAT PT WAS NOT HURT. THE RPTR HAS THAT GUN AS WELL BUT IT DID NOT COME WITH ANY PT INFO OR PACKAGING. HOSP IS PULLING ALL OF THESE DEVICES FROM USE IN HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55428 APPOSE ULC DISPOSABLE SKIN STAPLER WITH AUTO RELEASE GAG AMERICAN CYANAMID COMP US SURGICAL F62001/04 1108012

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR