BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 15707550 · Received November 1, 2022

    Report

    Report Number
    3005075853-2022-07444
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    May 7, 2022
    Report Date
    November 1, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PUBLICATION DATE: EXACT EVENT DATE UNK. BATCH #: UNK. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: POST-OPERATIVE HAEMORRHAGE SECONDARY TO CINNAMON USE. A CASE REPORT. AUTHOR: COURTENAY CHASE A, ALEX DOYLE A, SHABIER ST JOHN B, THERESA LAURENT C, SAHLE GRIFFITH A,B. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 95 (2022) 107179 HTTPS://DOI.ORG/10.1016/J.IJSCR.2022.107179. THIS STUDY PRESENTS A CASE REPORT OF A PATIENT DIAGNOSED WITH TRANSVERSE COLON ADENOCARCINOMA WHO UNDERWENT A LAPAROSCOPIC SUBTOTAL COLECTOMY IN A PRIVATE SURGICAL CENTRE. THE SURGERY WAS COMPLICATED BY SIGNIFICANT POST-OPERATIVE HAEMORRHAGE SECONDARY TO THE OVERZEALOUS USE OF CINNAMON. A CASE OF A 49-YEAR-OLD BLACK MALE WITH A HISTORY OF CELIAC DISEASE NOTED TWO EPISODES OF BRIGHT RED BLOOD MIXED WITH HIS STOOLS IN DECEMBER 2020. THE PATIENT'S HISTORY OF HAEMATOCHEZIA PROMPTED A VISIT TO A PRIVATE GASTROENTEROLOGIST. COLONOSCOPY SHOWED A 5 CM FRIABLE FUNGATING MASS 45 CM FROM THE ANAL VERGE, ALONG WITH MILD RIGHT-SIDED DIVERTICULOSIS. HISTOLOGY CONFIRMED A MODERATELY DIFFERENTIATED ADENOCARCINOMA.A LAPAROSCOPIC LEFT HEMICOLECTOMY WAS PLANNED TO BE PERFORMED. PREOPERATIVE BLOOD INVESTIGATIONS SHOWED HIS HAEMOGLOBIN TO BE 17.4 G/DL. A LAPAROSCOPIC LEFT HEMICOLECTOMY WAS PERFORMED BUT AN ABNORMALLY SHORT MESENTERY OF THE REMNANT COLON DID NOT FACILITATE A TENSION-FREE COLO-SIGMOID ANASTOMOSIS EVEN AFTER ATTEMPTS AT LENGTHENING THE MESENTERY. THE DECISION WAS MADE TO PERFORM A NEAR SUBTOTAL COLECTOMY WITH AN ILEO-SIGMOID ANASTOMOSIS. THE MIDDLE COLIC AND INFERIOR MESENTERIC VESSELS WERE ISOLATED AND LIGATED WITH AN ECHELON FLEX STAPLER WITH VASCULAR RELOADS. A LEAK TEST WAS PERFORMED WITH SATISFACTORY RESULTS. DAY ONE POST-OPERATION THE PATIENT WAS DIZZY WITH POSTURAL TACHYCARDIA. BLOOD INVESTIGATIONS SHOWED THE PATIENT'S HAEMOGLOBIN DECREASED FROM 17.4 G/DL TO 16 G/DL AND HE HAD MILD LEUKOCYTOSIS (12.97 K/UL). WITHIN 6 H HE DEVELOPED GENERALIZED PERITONITIS WITH FEATURES OF FOX SIGN (ECCHYMOSIS ALONG THE INGUINAL LIGAMENT). A DIAGNOSIS OF POSTOPERATIVE HAEMORRHAGE WAS MADE AND A DIAGNOSTIC LAPAROSCOPY PERFORMED. THIS REVEALED BLOOD WITHIN THE PERITONEAL CAVITY AND CLOT IN THE REGION OF THE MIDDLE COLIC VESSELS WHICH EXTENDED INTO THE RETROPERITONEAL SPACE, AND INFERIORLY INTO THE SPACE OF RETZIUS. THERE WAS NO ACTIVE BLEEDING. THE BOWEL APPEARED DILATED BUT THERE WERE NO SIGNS OF INTRAPERITONEAL SEPSIS. ENDOSCOPY WAS PERFORMED TO ENSURE THE ANASTOMOSIS WAS INTACT ALONG WITH A LEAK TEST WHICH WAS NEGATIVE. DAY ONE POST-RE-LAPAROTOMY HE HAD FLANK ECCHYMOSIS AND SCROTAL SWELLING. A BLEEDING DIATHESIS WAS CONSIDERED AND PROTHROMBIN TIME (PT), INTERNATIONAL NORMALIZED RATIO (INR), PARTIAL THROMBOPLASTIN TIME (PTT) AND LIVER FUNCTION TEST (LFT) WERE PERFORMED. UNFORTUNATELY, THROMBIN TIME AND FIBRINOGEN LEVELS WERE NOT AVAILABLE AT OUR INSTITUTION. THE DERANGED RESULTS WERE PT 22.5 S AND INR 1.59. HIS PTT (35.9 S) AND LFT WERE NORMAL. UPON FURTHER DIETARY INTERROGATION, THE PATIENT ADMITTED HE HAD BEEN CONSUMING ONE TABLESPOON OF CEYLON CINNAMON DAILY FOR THE PAST TEN MONTHS FOR ITS PURPORTED HEALTH BENEFITS. SIX HOURLY HAEMOGLOBIN LEVELS WERE ORDERED WHICH SHOWED HIS HAEMOGLOBIN DECREASED FROM 9.3 G/DL TO 8.0 G/DL. THE DECISION WAS MADE TO TRANSFUSE TWO UNITS OF PACKED RED BLOOD CELLS. THE PATIENT WAS ALSO TRANSFUSED 795 ML OF FRESH FROZEN PLASMA UNDER ADVISEMENT FROM THE ON-SERVICE HAEMATOLOGIST. THE PATIENT ALSO HAD THREE EPISODES OF BILIOUS VOMITING AND A NASOGASTRIC TUBE WAS PASSED. DAY TWO POST RELAPAROTOMY INVESTIGATIONS SHOWED A STABLE HAEMOGLOBIN OF 11.6 G/DL (POST-TRANSFUSION) AND PT 19.2 S/INR 1.32. THERE WAS NO MORE FRESH FROZEN PLASMA AVAILABLE. SERIAL BLOOD TESTS WERE DISCONTINUED. OVER THE FOLLOWING SEVEN DAYS NASOGASTRIC OUTPUT WAS GREATER THAN 1 L PER DAY. A CT SCAN OF THE ABDOMEN AND PELVIS WAS PERFORMED AND THE SCAN SHOWED THAT NO CONTRAST WAS ABLE TO GET PAST THE ANASTOMOSIS AND THE PATIENT WAS DIAGNOSED WITH ANASTOMOTIC STENOSIS (CLAVIEN-DINDO 3). RELAPAROTOMY WAS PERFORMED. THE STENOSED SEGMENT WAS RESECTED AND THE ANASTOMOSIS WAS REFASHIONED .DAY ONE POST- RELAPAROTOMY, THE PATIENT'S NASOGASTRIC TUBE WAS REMOVED AND HE TOLERATED SIPS OF CLEAR FLUIDS. A HEMATOMA DEVELOPED AT THE PFANNENSTIEL INCISION ON THE FIRST-DAY. BOWEL FUNCTION RETURNED DAY TWO POST-PROCEDURE BUT HE WAS NOW HAVING LARGE VOLUME FREQUENT WATERY STOOLS. HE WAS ALLOWED HOME WITH HOME NURSING AND SUPPLEMENTAL INTRAVENOUS FLUIDS. AT OUTPATIENT REVIEW THREE DAYS POST-DISCHARGE, HE WAS COMMENCED ON ANTIDIARRHEAL MEDICATION. ONE-WEEK POST-DISCHARGE HIS INR WAS 1.2 AND A BLEEDING TIME WAS DONE WHICH WAS NORMAL. A BLOOD FILM SHOWED NO MORPHOLOGICAL ABNORMALITIES TO THE BLOOD CELLS OR PLATELETS. IT WAS CONCLUDED, THAT THIS CASE EXEMPLIFIES THE IMPACT DIETARY PRACTICES CAN HAVE ON SURGICAL CARE AND IT IS OUR RECOMMENDATION THAT CLINICIANS TAKE A THOROUGH DIETARY HISTORY FOR ALL PATIENTS AND ENCOURAGE PATIENTS TO DISCONTINUE HERBAL REMEDIES TWO WEEKS PRIOR TO ELECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639531 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention