BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 8699646 · Received June 14, 2019

    Report

    Report Number
    3005075853-2019-19739
    Event Type
    Injury
    Date Received
    June 14, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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 SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: NEW LAPAROSCOPIC PROCEDURE FOR LEFT-SIDED PANCREATIC CANCER¿ARTERY-FIRST APPROACH LAPAROSCOPIC RAMPS USING 3D TECHNIQUE. AUTHOR: MICHIHIRO YAMAMOTO*, MASAZUMI ZAIMA, HIDEKAZU YAMAMOTO, HIDEKI HARADA, JUNICHIRO KAWAMURA, MASAHIRO YAMADA, TEKEFUMI YAZAWA AND JUNYA KAWASOE. CITATION: WORLD JOURNAL OF SURGICAL ONCOLOGY. 2017; 15: 213. DOI: 10.1186/S12957-017-1284-3. FOR LEFT-SIDED PANCREATIC DUCTAL ADENOCARCINOMA (PDAC), RADICAL ANTEGRADE MODULAR PANCREATOSPLENECTOMY (RAMPS) IS A REASONABLE SURGICAL APPROACH FOR TUMOR-FREE MARGIN RESECTION AND SYSTEMIC LYMPH NODE CLEARANCE. THE AUTHORS DEVELOPED THE ARTERY-FIRST APPROACH L-RAMPS FOR LEFT-SIDED PDAC AND HAVE PRESENTED THE SAME IN THIS REPORT. BETWEEN JUNE 2014 AND JULY 2015, A TOTAL OF 16 PATIENTS WITH LEFT-SIDED PDAC WERE REFERRED TO THE DIVISION FOR PANCREATIC RESECTION. THE ARTERY-FIRST L-RAMPS USING A 3D TECHNIQUE WAS POTENTIALLY APPLICABLE TO 8 OF THE 16 CASES PREOPERATIVELY BASED ON OUR INDICATION CRITERIA PERTAINING TO TUMOR-RELATED VARIABLES AND PHYSICAL CONDITIONS OF THE PATIENT. HOWEVER, FIVE OUT OF THE EIGHT PATIENTS OPTED FOR OPEN SURGERY. IN ALL, THE ARTERY-FIRST L-RAMPS USING A 3D TECHNIQUE WAS SUCCESSFULLY PERFORMED IN THREE PATIENTS. DURING THE SURGICAL PROCEDURE, THE NECK, INCLUDING THE TRANSVERSE PANCREATIC ARTERY, WAS LAPAROSCOPICALLY TRANSECTED USING AN ECHELON FLEX 60 MM LINEAR STAPLING DEVICE (ETHICON). REPORTED COMPLICATION INCLUDED CASE 2, A (B)(6) FEMALE PATIENT WITH PANCREATIC FISTULA AND WAS TREATED WITH CONSERVATIVE MANAGEMENT. THE NEW LAPAROSCOPIC PROCEDURE FOR LEFT-SIDED PDAC, ARTERY-FIRST L-RAMPS USING A 3D TECHNIQUE, WAS SAFE AND FEASIBLE TO PERFORM. THIS PROCEDURE IS ADVANTAGEOUS AS IT ALLOWED MINIMAL INTRAOPERATIVE BLOOD LOSS AND PRECISE LYMPHADENECTOMY. WITH SEVERAL THEORETICAL ADVANTAGES, THE AUTHORS BELIEVED THIS NOVEL TECHNIQUE MAY BECOME THE PREFERRED TREATMENT FOR LEFT-SIDED PDAC IN SELECTED CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494632 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention