BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 9368963 · Received November 25, 2019

    Report

    Report Number
    3005075853-2019-23746
    Event Type
    Injury
    Date Received
    November 25, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (.B)(4) EVENT DATE UNK. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. PLEASE PROVIDE THE SPECIFIC NUMBER OF PATIENTS WHO HAD SIGNIFICANT NUMBER OF PERIOPERATIVE BLOOD LOSS WITH THE USE OF HARMONIC SCALPEL IN LAPAROSCOPIC LIVER RESECTION GROUP. PLEASE PROVIDE THE SPECIFIC NUMBER OF PATIENTS WHO HAD EVENT OF INFECTION, BILIARY LEAK, FLUID COLLECTIONS, BLEEDING WITH THE USE OF ETHICON DEVICE REPORTED FOR BOTH GROUPS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: ROBOTIC VERSUS LAPAROSCOPIC RESECTIONS OF POSTEROSUPERIOR SEGMENTS OF THE LIVER: A PROPENSITY SCORE-MATCHED COMPARISON. AUTHORS: ROBERTO MONTALTI; VINCENZO SCUDERI; ALBERTO PATRITI; MARCO VIVARELLI; ROBERTO I. TROISI. CITATION: SURG ENDOSC (2016) 30:1004¿1013; DOI 10.1007/S00464-015-4284-9. THE AIM OF THIS PROSPECTIVE STUDY WAS TO COMPARE MINOR ROBOTIC LIVER RESECTIONS TO LAPAROSCOPIC LIVER RESECTIONS FOR TUMORS LOCATED IN POSTEROSUPERIOR (PS) SEGMENTS IN A 2:1 CASE CONTROL STUDY MATCHED BY PROPENSITY SCORE ANALYSIS IN ORDER TO INVESTIGATE INTRA- AND POSTOPERATIVE OUTCOMES OF THE TWO TECHNIQUES IN CONDITIONS WHERE PARENCHYMAL-PRESERVING RESECTIONS WERE PERFORMED. BETWEEN JUNE 2008 AND FEBRUARY 2014, 36 PATIENTS (MALE=21; MEAN AGE=62 ± 13 YEARS, AGE RANGE=32-84 YEARS) UNDERWENT ROBOT-ASSISTED LIVER RESECTION WERE MATCHED WITH 72 PATIENTS (MALE=39; MEAN AGE=56.8 ± 15 YEARS, AGE RANGE=17-79 YEARS) UNDERGOING LAPAROSCOPIC LIVER RESECTION. IN ROBOTIC LIVER RESECTIONS GROUP, HEMOSTASIS OF SMALL VESSELS WAS OBTAINED USING A MONOPOLAR OR BIPOLAR CAUTERY. TO SECURE LARGER VESSELS ON THE TRANSECTION LINE, HEM-O-LOCK CLIPS OR LIGATURES WITH VICRYL OR PROLENE (ETHICON) WERE USED. THE HEPATIC VEINS WERE USUALLY DIVIDED WITH A LAPAROSCOPIC LINEAR STAPLER (ENDOGIA, ETHICON) OR SUTURED. IN LAPAROSCOPIC LIVER RESECTION GROUP, PARENCHYMA DIVISION WAS PERFORMED USING SURGICAL ASPIRATOR AND A HARMONIC SCALPEL (ETHICON) FOR THE GLISSONIAN APPROACH. LARGER VASCULAR/BILIARY STRUCTURES WERE CONTROLLED WITH THE ENDOCLIPS OR VASCULAR STAPLERS (ENDOGIA, ETHICON; TRI-STAPLER TECHNOLOGY, COVIDIEN). REPORTED COMPLICATIONS IN ROBOTIC LIVER RESECTIONS GROUP INCLUDED INFECTION [PROLENE OR VICRYL (N=?), ENDOGIA (N=?)], BILIARY LEAK [ENDOGIA (N=?)]; FLUID COLLECTIONS [ENDOGIA (N=?)]; VCI SYNDROME [ENDOGIA (N=1)]; BLEEDING [ENDOGIA (N=?)]. REPORTED COMPLICATIONS LAPAROSCOPIC LIVER RESECTION GROUP INCLUDED INFECTION [ENDOGIA (N=?]; BILIARY LEAK [ENDOGIA (N=?)]; BLEEDING [ENDOGIA (N=?)]; FLUID COLLECTIONS [ENDOGIA (N=?)]; PERIOPERATIVE BLOOD LOSS [HARMONIC SCALPEL (N=?)]. IN CONCLUSION, ROBOT-ASSISTED RESECTIONS IN THE PS SEGMENTS ARE COMPARABLE IN SAFETY AND FEASIBILITY TO PURE LLR IN A HIGH-VOLUME CENTER, ALTHOUGH A TREND TO A HIGHER DEGREE OF COMPLICATIONS WAS RECORDED WITH THE ROBOTIC TECHNIQUE. HOWEVER, BASED ON OUR RESULTS USING PROPENSITY MATCHING, THE CLAIMED SUPERIORITY OF ROBOTICS OVER THE LAPAROSCOPIC APPROACH HAS NOT BEEN PROVEN FOR PS SEGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162827 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention