BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITINOL COMPRESSION ANASTOMOTIC DEVICE

    MDR report key: 3032525 · Received March 28, 2013

    Report

    Report Number
    MW5029559
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 28, 2013
    Manufacturer
    UNKNOWN
    Product Code
    LNN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT HAD A LAPAROSCOPIC LOW ANTERIOR RESECTION FOR A DIVERTICULAR STRICTURE AT THE RECTOSIGMOID JUNCTION. PT DID WELL AND WAS SENT HOME ON POST-OP DAY 3. ON (B)(6) 2013, PT WAS HAVING A BOWEL MOVEMENT AND EXPERIENCED SUDDEN ONSET OF SEVERE PAIN. WAS TAKEN TO THE EMERGENCY ROOM WHERE PHYSICAL EXAM AND LABS WERE CONSISTENT WITH POSSIBLE SEPSIS. PT TAKEN TO THE OPERATING ROOM, ABDOMEN OPENED WHERE A SIGNIFICANT AMOUNT OF PURULENCE AND FECULENCE WAS WASHED OUT. ENTIRE BOWEL RUN WITH NO PROBLEMS FOUND UNTIL SITE OF THE COLORECTAL ANASTOMOSIS WAS REACHED. THE COMPRESSION RING THAT WAS USED TO PERFORM THE ANASTOMOSIS WAS PRESENT AT THE RECTAL JUNCTION OPEN TO THE ABDOMEN AND WAS EASILY REMOVED WITHOUT ANY FORCE. ANASTOMOTIC DISRUPTION SUSPICIOUS FOR FAILURE OF THE COMPRESSION STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127324 NITINOL COMPRESSION ANASTOMOTIC DEVICE UNKNOWN LNN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R