BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 7727673 · Received July 27, 2018

    Report

    Report Number
    3005075853-2018-11613
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    June 1, 2007
    Report Date
    June 27, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: LAPAROSCOPIC INTRACORPOREAL DISTAL RECTAL TRANSECTION WITH THE CONTOUR DEVICE AUTHOR: L. ALEVIZOS, M. M. LIRICI CITATION: TECH COLOPROCTOL (2012) 16:379¿383; DOI 10.1007/S10151-012-0818-5; PUBLISHED ONLINE: 17 MARCH 2012. THE AIM OF THIS PAPER WAS TO DESCRIBE LAPAROSCOPIC TECHNIQUE OF RECTAL TRANSECTION BY CURVED CUTTER IN A SERIES OF 34 PATIENTS WITH CANCER OR ULCERATIVE COLITIS AND PRESENT DATA CONCERNING THEIR DEMOGRAPHIC CHARACTERISTICS AND OUTCOMES. BETWEEN JUNE 2007 AND MARCH 2011, 34 PATIENTS (18 MALES AND 16 FEMALES) WHO UNDERWENT LAPAROSCOPIC CURVED CUTTER RECTAL CANCER TRANSECTION WERE INCLUDED IN THE STUDY. THERE WERE 28 PATIENTS AFTER LOW ANTERIOR RECTAL RESECTION (LARR) WITH TOTAL MESORECTAL EXCISION (TME), 3 AFTER RESTORATIVE PROCTOCOLECTOMY (2 WITH J-POUCH-ANAL ANASTOMOSIS AND 1 WITH ILEORECTAL ANASTOMOSIS), 1 AFTER SUBTOTAL PROCTOCOLECTOMY WITH ILEORECTAL ANASTOMOSIS, 1 AFTER LEFT COLECTOMY AND 1 AFTER HARTMANN¿S PROCEDURE. DURING THE PROCEDURE, THE 10-MM TROCAR INCISION ON THE RIGHT INGUINAL REGION IS EXTENDED MEDIALLY UP TO 5 CM, AND THROUGH THIS MINI LAPAROTOMY, A CURVED CUTTER (CONTOUR- JOHNSON & JOHNSON¿NEW BRUNSWICK, NJ, USA). THE STAPLING DEVICE IS INSERTED AND THE STERILE DRAPE IS WRAPPED AROUND ITS SHAFT AND PULLED UP. SUCH A MANEUVER MAKES IT POSSIBLE TO MAINTAIN ENOUGH PRESSURE INSIDE THE PERITONEAL CAVITY TO DRIVE THE CURVED CUTTER INTO THE PELVIS UNDER LAPAROSCOPIC GUIDANCE. THEN, THE RECTAL DISSECTION AND TRANSECTION BY THE CURVED CUTTER CONTINUE AS DESCRIBED ABOVE. FINALLY, EITHER A DOUBLE-STAPLED J-POUCH-ANAL CANAL ANASTOMOSIS OR AN ILEORECTAL ANASTOMOSIS IS PERFORMED. POSTOPERATIVE COMPLICATIONS WERE OBSERVED IN 4 PATIENTS (12.5%). TWO PATIENTS HAD SUBCLINICAL ANASTOMOTIC LEAKS THAT WERE DEMONSTRATED AT THE POSTOPERATIVE CONTRAST ENEMA BUT REMAINED ASYMPTOMATIC. THEREFORE, THEY WERE MANAGED CONVENTIONALLY BUT THE ILEOSTOMY CLOSURE WAS POSTPONED. ONE PATIENT DEVELOPED A PARTIAL DEHISCENCE OF THE SUTURE LINE AND FEVER RESULTING IN AN ANASTOMOTIC STENOSIS IDENTIFIED AT THE ENDOSCOPY PERFORMED 1 MONTH LATER, BEFORE ILEOSTOMY CLOSURE. THE PATIENT WAS TREATED WITH DILATIONS RESULTING IN ALMOST COMPLETE RECOVERY, AND THE ILEOSTOMY CLOSURE WAS PERFORMED IN THE 3RD POSTOPERATIVE MONTH. IN CONCLUSION, LOW RECTAL TRANSECTION WITH A CURVED CUTTER MAY ALLOW SURGEONS TO ACCOMPLISH SUCH A CHALLENGING STEP NOT ONLY IN OPEN BUT EVEN IN LAPAROSCOPIC PROCEDURES, PROVIDING A CLOSE TO OPTIMAL CLOSURE/DIVISION OF THE RECTAL STUMP. THE LEAKAGE RATE AFTER LAPAROSCOPIC AND OPEN CURVED CUTTER RECTAL TRANSECTION SEEMS TO BE SIMILAR; FURTHERMORE, PRELIMINARY POSTOPERATIVE RESULTS SHOW THAT THE USE OF A CURVED CUTTER FOR LAPAROSCOPIC LOW RECTAL DIVISION IN SELECTED PATIENTS MAY OFFER ADVANTAGES COMPARED TO OTHER CURRENT TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567748 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention