BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 14501233 · Received May 25, 2022

    Report

    Report Number
    1219930-2022-01957
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    January 9, 2021
    Report Date
    May 25, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: IMPLEMENTATION AND TRAINING WITH LAPAROSCOPIC DISTAL PANCREATECTOMY: 23-YEAR EXPERIENCE FROM A HIGH-VOLUME CENTER SOURCE: SURGICAL ENDOSCOPY (2022) 36:468¿479. HTTPS://DOI.ORG/10.1007/S00464-021-08306-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN APRIL 1997 AND JUNE 2020,  A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC DISTAL PANCREATECTOMY BY FOUR SURGEONS. DURING THE PROCEDURE, THE DEVICE WAS USED TO DIVIDE THE SPLENIC VESSELS AND TO TRANSECT THE PANCREAS. THERE WERE 640 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: INTRAOPERATIVE BLEEDING WITH A MEDIAN OF SIXTY MILLILITERS WAS OBSERVED. PERIOPERATIVE RED BLOOD CELL TRANSFUSION WAS DONE FOR 57 PATIENTS, 33 PATIENTS HAD GRADE B/C HEMORRHAGE. CONVERSION TO OPEN SURGERY WAS NEEDED IN 14 (2.2%) PATIENTS, 6 OF THOSE DUE TO MAJOR INTRAOPERATIVE BLEEDING AND THE REMAINING 8 DUE TO ADHERENCE TO THE MAJOR VESSELS POTENTIALLY REQUIRING VASCULAR RESECTION AND RECONSTRUCTION. POSTOPERATIVE COMPLICATIONS DEVELOPED IN 224 (35%) PATIENTS INCLUDING 119 (18.6%) WITH GRADE B/C PANCREATIC FISTULA. REOPERATION WAS DONE IN 34 (5.3%) CASES, AND MEDIAN POSTOPERATIVE LENGTH OF STAY WAS 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342574 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention| H| O