BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 1770184 · Received July 20, 2010

    Report

    Report Number
    1219930-2010-00557
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    January 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    PROCEDURE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: ORIGINAL SURGERY WAS COMPLETED ON (B) (6)2010 (B) (4) SIGMOIDOSCOPY, FLEXIBLE; WITH DIRECTED SUBMUCOSAL INJECTION(S), ANY SUBSTANCE. THIS SURGERY WAS COMPLETED TO TATTOO THE RESECTION POINT ON THE COLON IN PREPARATION FOR SURGERY THE NEXT DAY. SECOND SURGERY WAS COMPLETED ON (B) (6)20/10 (B) (4) COLECTOMY, PARTIAL; WITH COLOPROCTOSTOMY LOW PELVIC ANASTOMOSIS, THIRD SURGERY WAS COMPLETED ON (B) (6)2010 (B) (4) COLOSTOMY OR SKIN LEVEL CECOSTOMY; A LOOP COLOSTOMY WAS PERFORMED DUE TO LEAKING STOOL BEING PRESENT IN THE DRAIN. FOURTH SURGERY WAS COMPLETED ON (B) (6)2010 (B) (4) INCISION AND DRAINAGE OF ABSCESS EG, CARBUNCLE, SUPPURATIVE HIDRADENITIS, CUTANEOUS OR SUBCUTANEOUS ABSCESS, CYST, FURUNCLE, OR PARONYCHIA; COMPLICATED OR MULTIPLE. A RIGHT COLOSTOMY WAS PERFORMED. FIFTH SURGERY WAS COMPLETED ON (B) (6)2010 (B) (4) REVISION OF COLOSTOMY; COMPLICATED RECONSTRUCTION IN-DEPTH SEPARATE PROCEDURE. A LOOP COLOSTOMY WAS PERFORMED FOR PROLAPSING COLON. NO FURTHER PRODUCT INFORMATION AVAILABLE. THERE WERE NO DISCREPANCIES NOTED WITH USE OF THE EEA DEVICE. AN AIR LEAK TEST WAS PERFORMED DURING THE PROCEDURE WITH NORMAL RESULTS. DURING THE SURGERY, THE EEA CIRCULAR STAPLER PERFORMED AS EXPECTED AND THE LEAK TEST WAS ACCEPTABLE. THERE WAS NOTHING UNUSUAL EXPERIENCED DURING THE SURGERY, THEREFORE, THERE WAS NO ADDED SURGICAL TIME, NO UNEXPECTED BLOOD LOSS, AND NO PATIENT INJURY REPORTED. THE REPORTED INCIDENT OCCURRED POST-OP. UPON INSPECTION IN THE OPERATING ROOM WHEN THE PATIENT WAS BROUGHT BACK, THE SURGEON WAS UNABLE TO IDENTIFY IF THE LEAK WAS ON THE EEA STAPLE LINE OR ETHICON'S CONTOUR STAPLE LINE. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN EEA DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other