BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAPLING DEVICE

    MDR report key: 10767303 · Received October 31, 2020

    Report

    Report Number
    2647580-2020-03573
    Event Type
    Injury
    Date Received
    October 31, 2020
    Date of Event
    May 4, 2016
    Report Date
    October 31, 2020
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ROBOTIC-ASSISTED APPROACH IMPROVES VESSEL PRESERVATION IN SPLEEN-PRESERVING DISTAL PANCREATECTOMY SOURCE: DIG SURG 2016;33:406¿413, DOI: 10.1159/000444269 016. S. KARGER AG, BASEL 0253¿4886/16/0335¿0406$39.50/0. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, (SEPTEMBER 2009 AND MAY 2015) THIS STUDY AIMED TO ASSESS THE OUTCOME OF A ROBOTIC-ASSISTED LAPAROSCOPIC DP (RA-LDP) AND ITS RATE OF VESSEL PRESERVATION AND SP COMPARED TO CONVENTIONAL LAPAROSCOPIC DP (C-LDP). A DEVICE STAPLER WAS USED IN THE PROCEDURE. 29 PATIENT WAS UNDERGO CONVENTIONAL LAPAROSCOPIC DISTAL PANCREATECTOMY (C-LDP) AND 12 PATIENT UNDERGO A ROBOTIC ASSISTED LAPAROSCOPIC DISTAL PANCREATECTOMY (RA-LDP). IN THE CONVENTIONAL GROUP (C-LDP), 3/29 (10%) HAD POST-OPERATIVE HEMORRHAGE AND 3/29 (10%) REQUIRED RE-OPERATION. IN THE ROBOTIC ASSISTED GROUP (RA-LDP), 2/12 (17%) HAD POST-OPERATIVE HEMORRHAGE AND 2/12 (17%) REQUIRED RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232001 UNKNOWN STAPLING DEVICE STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN STAPLING DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R