BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 8704320 · Received June 17, 2019

    Report

    Report Number
    3005075853-2019-19806
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    January 1, 2018
    Report Date
    May 23, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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/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 VIA JOURNAL ARTICLE TITLE: APPLICATION OF A COMMERCIAL SINGLE-PORT DEVICE FOR ROBOTIC SINGLE INCISION DISTAL PANCREATECTOMY: INITIAL EXPERIENCE. AUTHORS: CHENG-MING PENG, HSIN-CHENG LIU, CHING-LUNG HSIEH, YAO-KUN YANG, TENG-CHIEH CHENG, RUEY-HWANG CHOU, YI-JUI LIU. CITATION: SURGERY TODAY (2018); 48:680¿686. DOI: HTTPS://DOI.ORG/10.1007/S00595-018-1647-6. THE AUTHORS DESCRIBE HOW THEY APPLIED THE COMMERCIAL SINGLE PORT WITH MODIFICATION TO MAKE ROBOTIC SINGLE INCISION DISTAL PANCREATECTOMY FEASIBLE AND SAFE. BETWEEN JULY 1, 2015 AND DECEMBER 31, 2016, 10 PATIENTS (3 MALE AND 7 FEMALE; AGE RANGE: 36¿67 YEARS) UNDERWENT ROBOTIC-ASSISTED SINGLE-INCISION DISTAL PANCREATECTOMY FOR BENIGN OR MALIGNANT TUMORS. THE PANCREATIC AND SPLENIC VESSELS ARE ABLE TO BE HUNG UP AFTER COMPLETE DISSECTION. THEY WERE THEN TRANSECTED WITH ECHELON 60 SURGICAL STAPLER (ETHICON). THE STAPLER LINE IS REINFORCED WITH 3¿0 PROLENE SUTURES (ETHICON) FOR HEMOSTASIS AND TO PREVENT PANCREATIC LEAKAGE. REPORTED COMPLICATIONS INCLUDED: PATIENT 1, A (B)(6) MALE PATIENT WITH SPLENIC FOSSA HEMATOMA CAUSING LEFT UPPER ABDOMINAL DULL PAIN WHICH WAS TREATED EFFECTIVELY WITH PERCUTANEOUS DRAINAGE AND THE PATIENT WAS DISCHARGED. PATIENT 3, A (B)(6) FEMALE PATIENT WITH PANCREATIC LEAKAGE IN WHICH THE PATIENT TOLERATED ORAL INTAKE WELL AFTER CONSERVATIVE TREATMENT. THE DRAINAGE TUBE WAS REMOVED ABOUT 2 WEEKS POSTOPERATIVELY. PATIENT 10, A (B)(6) FEMALE PATIENT WITH BLOOD LOSS (250 ML) AND PANCREATIC LEAKAGE IN WHICH THE PATIENT TOLERATED ORAL INTAKE WELL AFTER CONSERVATIVE TREATMENT. THE DRAINAGE TUBE WAS REMOVED ABOUT 2 WEEKS POSTOPERATIVELY. IN CONCLUSION, THE RESULTS DEMONSTRATE THE SAFETY AND EFFICIENCY OF ROBOTIC SINGLE-INCISION DISTAL PANCREATECTOMY VIA THE MODIFIED PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497196 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention