BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 9416299 · Received December 5, 2019

    Report

    Report Number
    3005075853-2019-23989
    Event Type
    Injury
    Date Received
    December 5, 2019
    Report Date
    November 7, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE: 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/AUTHOR 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 : THE UNCINATE PROCESS FIRST APPROACH IN LAPAROSCOPIC PANCREATICODUODENECTOMY: A SINGLE-INSTITUTION EXPERIENCE. AUTHOR : ZHANG, YUE PHD; SUN, DONG-LIN MD; CHEN, XUE-MIN MD. CITATION: SURGICAL LAPAROSCOPY, ENDOSCOPY & PERCUTANEOUS TECHNIQUES VOLUME 27(6), DECEMBER 2017, P E141-E144 / DOI: 10.1097/SLE.0000000000000476. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE FEASIBILITY, SAFETY, AND EFFICACY OF LPD USING THE UNCINATE PROCESS FIRST APPROACH. BETWEEN JUNE 2015 AND JAN 2017, A TOTAL OF 45 PATIENTS (N=20 WOMEN, N=25 MEN, MEAN AGE WAS 63 ± 12 YEARS, MEDIAN BODY MASS INDEX WAS 24 ± 3) UNDERWENT LPD FOR PERIAMPULLARY TUMORS, BILE DUCT CARCINOMA, INTRADUCTAL PAPILLARY MUCINOUS NEOPLASMS, AND PANCREATIC HEAD CANCER BY A SINGLE SURGEON. THE GASTROCOLIC LIGAMENT WAS DISSECTED BELOW THE GASTROEPIPLOIC VESSELS USING A ULTRASONIC DISSECTOR (HARMONIC SCALPEL, ETHICON ENDO-SURGERY), AND THEN, THE LEFT AND RIGHT COLONIC FLEXURES WERE ALSO DISSECTED. THE RIGHT GASTROEPIPLOIC VESSELS WERE IDENTIFIED, LIGATED WITH HEMOLOCK CLIPS, AND THEN TRANSECTED USING AN ULTRASONIC DISSECTOR. THE JEJUNUM WAS TRANSECTED 15 CM DISTAL FROM THE TREITZ LIGAMENT USING AN ENDOSCOPIC LINEAR STAPLER (ENDOCUTTER 60 STAPLER, WHITE CARTRIDGE; ETHICON ENDO-SURGERY). THE UNCINATE PROCESS WAS DISSECTED USING ULTRASONIC DISSECTOR ALONG THE SURFACE OF THE PANCREATIC PARENCHYMA WHEN THE JEJUNUM WAS RETRACTED TO THE RIGHT. THE STOMACH WAS THEN DIVIDED PROXIMAL TO THE ANTRUM WITH AN ENDOSCOPIC LINEAR STAPLER (ENDOCUTTER 60 STAPLER, GOLDEN CARTRIDGE; ETHICON ENDO-SURGERY), THE PANCREATIC NECK PARENCHYMA WAS DIVIDED WITH ULTRASONIC DISSECTOR. AN END-TO-SIDE PANCREATICOJEJUNOSTOMY (DUCT-TO-MUCOSA) WAS FASHIONED FIRST USING AN INTERRUPTED 5-0 POLYSORB DEXON S (ETHICON). AN END-TO-SIDE CHOLEDOCHOJEJUNOSTOMY WAS FASHIONED WITH A CONTINUOUS SINGLE LAYER USING VICRYL 4-0 (ETHICON). THE GASTROJEJUNOSTOMY IS PERFORMED ANTECOLIC USING A STAPLED TECHNIQUE (ENDOCUTTER 60 STAPLER, BLUE CARTRIDGE; ETHICON ENDO-SURGERY). COMPLICATIONS INCLUDED POSTOPERATIVE PANCREATIC FISTULA (N=4) WHICH WAS MANAGED CONSERVATIVELY AND ULTIMATELY CURED; PERITONEAL LAVAGE AND PLACEMENT OF DRAINAGE TUBES WERE PERFORMED LAPAROSCOPICALLY IN 1 PATIENT DIAGNOSED WITH A GRADE C PANCREATIC FISTULA; AND DELAYED GASTRIC EMPTYING (N=2). IN CONCLUSION, LPD WITH THE UNCINATE PROCESS FIRST APPROACH WELL COMBINES THE BENEFITS OF LAPAROSCOPY WITH LOW RISK OF POSTOPERATIVE COMPLICATIONS AND HIGH RATE OF CURATIVE RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213778 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention