BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 8704221 · Received June 17, 2019

    Report

    Report Number
    3005075853-2019-19803
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    January 1, 2017
    Report Date
    May 23, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001072
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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: EN BLOC STAPLING OF THE RENAL HILUM DURING LAPAROSCOPIC NEPHRECTOMY: A DOUBLE-INSTITUTIONAL ANALYSIS OF SAFETY AND EFFICACY AUTHORS: BENJAMIN A. SHERER, ALEXANDER K. CHOW, MATTHEW J. NEWSOME, CHRISTOPHER L. COOGAN, SANDIP M. PRASAD, AND KALYAN C. LATCHAMSETTY. CITATION: UROLOGY (2017); 105: 69¿75. DOI: HTTP://DX.DOI.ORG/10.1016/J.UROLOGY.2017.01.051. THE AIM OF THIS STUDY IS TO SUPPORT THE SAFETY AND EFFICACY OF EN BLOC STAPLING OF THE RENAL HILUM (EBSH) DURING LAPAROSCOPIC NEPHRECTOMY (LNX) IN A LARGE DOUBLE-INSTITUTION COHORT WITH AN EXTENDED FOLLOW-UP PERIOD. THIS RETROSPECTIVE STUDY INVOLVES 428 PATIENTS (236 MALE AND 193 FEMALE; AGE RANGE: 22-87 YEARS) WHO UNDERWENT LNX WITH EBSH BETWEEN 2008 AND 2014. IN TOTAL, 433 RENAL UNITS WERE INCLUDED IN THIS REVIEW, AS BILATERAL NEPHRECTOMY WAS PERFORMED IN 5 PATIENTS. STANDARD TRANSPERITONEAL LNX DISSECTION WAS PERFORMED, AND STAPLING OF THE RENAL HILUM WAS ACCOMPLISHED WITH ENDOPATH, ETS-FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER; 45 MM STAPLE LINE, 2.5 MM STAPLE LENGTH ENDOVASCULAR STAPLER (ETHICON). REPORTED COMPLICATIONS INCLUDED STAPLER MALFUNCTION WHICH RESULTED TO INCOMPLETE LIGATION OF THE RENAL ARTERY (N-1), AND ACUTE PERIOPERATIVE BLOOD LOSS IN THE SETTING OF CHRONIC ANEMIA (N-5) IN WHICH THE PATIENTS RECEIVED PERIOPERATIVE BLOOD TRANSFUSION. IN CONCLUSION, EBSH DURING LNX IS EFFICIENT, EFFECTIVE, AND SAFE. THIS LARGE SERIES LENDS FURTHER SUPPORT THAT EBSH DURING LNX MAY NOT BE ASSOCIATED WITH ANY SIGNIFICANT RISK OF AVF FORMATION AT EXTENDED FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497153 ETS FLEX ARTICNG LNR CUTR 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036001072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention