BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1219930-2014-00903

    MDR report key: 4131365 · Received October 1, 2014

    Report

    Report Number
    1219930-2014-00903
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    October 11, 2012
    Report Date
    September 10, 2014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE REPORTER: ON (B)(6) 2012 THE (B)(6) MALE PATIENT HAD LOW ANTERIOR RESECTION TO TREAT DIVERTICULITIS WITH MICROPERFORATION, LAPAROSCOPIC MOBILIZATION OF SPLENIC FLEXURE, UMBILICAL HERNIA REPAIR AND SIGMOIDOSCOPY. THE RECTUM WAS DIVIDED WITH A COVIDIEN ENDO GIA 60 WITH PURPLE LOAD. TWO FIRINGS WERE USED TO CROSS THE RECTUM. ONCE THE RECTUM WAS DIVIDED, THE COLON WAS RETRACTED ANTERIORLY AND SUPERIORLY. THE ADDITIONAL MESENTERY WAS DIVIDED WITH LIGASURE DEVICE. THE SUPERIOR RECTAL STALK WAS IDENTIFIED AND SKELETONIZED WITH LIGASURE DEVICE AND THEN DIVIDED WITH THE COVIDIEN ENDO GIA WITH 45 MM GOLD LOAD. THIS WAS CONTINUED PROXIMALLY UNTIL THE SIGMOID AND DESCENDING COLON WERE FULLY MOBILIZED. THE 28 EEA STAPLER WAS PLACED INTO THE ENTEROTOMY AND PURSESTRING TIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012 PATIENT RETURNED WITH PERFORATION OF THE COLON POST PREP FOR COLONOSCOPY AND POSSIBLE ANASTOMOTIC LEAK. HE PRESENTED WITH DISTENDED ABDOMEN AND FLUID COLLECTION AROUND HIS ANASTOMOSIS WHICH WAS DRAINED. CT SCAN CONFIRMED LARGE FLUID COLLECTION WITH SIGNIFICANT AMOUNT OF FREE AIR. REOPERATION COMPLETED ON (B)(6) 2012 FOR PRIMARY REPAIR OF COLONIC ANASTOMOSIS. ON (B)(6) 2012 PATIENT HAD ABDOMINAL WASHOUT AND FASCIAL CLOSURE. PATIENT WAS DISCHARGED ON (B)(6) 2012 IN GOOD CONDITION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT EXPERIENCED ABDOMINAL LEAKING AND BACTERIAL INFECTION RELATED TO OR PRECIPITATED BY THE BREAKDOWN AND/OR FAILURE OF THE SURGICAL ANASTOMOSIS.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention