BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 13178667 · Received January 6, 2022

    Report

    Report Number
    1219930-2022-00097
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    July 6, 2021
    Report Date
    January 6, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: PARENCHYMAL-SPARING HEPATECTOMY FOR COLORECTAL LIVER METASTASES REDUCES POSTOPERATIVE MORBIDITY WHILE MAINTAINING EQUIVALENT ONCOLOGIC OUTCOMES COMPARED TO NON-PARENCHYMAL-SPARING RESECTION SOURCE: SURGICAL ONCOLOGY VOLUME 38, SEPTEMBER 2021, 101631. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT LIVER RESECTION FOR COLORECTAL LIVER METASTASES (CRLM) BETWEEN 2012 AND 2019. THE AIM OF THE STUDY WAS TO COMPARE THE POSTOPERATIVE OUTCOMES AND LONG-TERM SURVIVALS OF PATIENTS UNDERGOING PARENCHYMAL-SPARING RESECTION (PSR) WITH THOSE PATIENTS UNDERGOING NON-PSR IN THE ENTIRE COHORT OF CONSECUTIVE PATIENTS TREATED IN THE CENTER CRLM AFTER STRATIFYING THE PATIENTS ACCORDING TO THE BURDEN THE TUMOR BURDEN SCORE. PARENCHYMAL TRANSECTIONS WERE PERFORMED WITH THE STAPLER COMBINED WITH OTHER DEVICES. THERE WERE 153 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: POSTOPERATIVE BLEEDING. BLOOD TRANSFUSIONS WERE REQUIRED. NO OTHER INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739230 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention