BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM SILS PORT

    MDR report key: 3212770 · Received July 1, 2013

    Report

    Report Number
    1219930-2013-00498
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K082619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPY. ACCORDING TO THE REPORTER: THE MAJOR COMPLICATION WAS A RECTAL INJURY THAT OCCURRED DURING INSERTION OF THE ACCESS PORT FOR A PURE TV VHR. THE COLPOTOMY WAS DILATED AND A SILS PORT INTRODUCED. AFTER THE CAMERA WAS PLACED THROUGH THE PORT, A SMALL WINDOW WAS IDENTIFIED; ON INTRODUCTION OF THE CAMERA, STOOL AND THE RECTAL LUMEN WERE NOTED. A FLEXIBLE SIGMOIDOSCOPY WAS PERFORMED, AND THE RECTAL INJURY WAS SEEN AT ABOUT 20 CM WITH A CAMERA. BEFORE THE SILS PORT WAS REMOVED, THREE LAPAROSCOPIC PORTS WERE PLACED. ON INSPECTION, THE ONLY INJURY IDENTIFIED WAS A SMALL HEMATOMA WITHIN THE MESOSIGMOID COLON. THE COLPOTOMY WAS CLOSED WITH A RUNNING SUTURE. A SILS PORT WAS PLACED IN THE ANUS AND AN UPPER ENDOSCOPE WAS INTRODUCED THROUGH THE 12 MM PORT. THE PERFORATION WAS SUCCESSFULLY CLOSED WITH SUTURES. A LEAK TST WAS CONSISTENT WITH AN AIRTIGHT REPAIR. POSTOPERATIVELY, THE PT WAS PLACED ON INTRAVENOUS ANTIBIOTICS WITH BOWEL REST FOR 2 DAYS AWAITING BOWEL FUNCTION. THE PT WAS DISCHARGED ON POSTOPERATIVE DAY 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298018 5MM SILS PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other