BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EGIA TRI STAPLE

    MDR report key: 11996144 · Received June 14, 2021

    Report

    Report Number
    1219930-2021-02349
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    June 1, 2020
    Report Date
    June 14, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: POSTOPERATIVE RISK OF PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY WITH OR WITHOUT SPLEEN PRESERVATION SOURCE: TUMORI JOURNAL 2021, VOL. 107(2) 160¿165. ACCEPTED: 1 JUNE 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A STUDY COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT DISTAL PANCREATECTOMY WITH AND WITHOUT SPLENECTOMY BETWEEN JANUARY 2011 AND DECEMBER 2017. 48 PATIENTS WERE INCLUDED IN THE STUDY: 26 UNDERWENT DISTAL PANCREATECTOMY WITH SPLENECTOMY (DPS) AND 22 UNDERWENT SPLEEN PRESERVING DISTAL PANCREATECTOMY (SPDP). THE ENDOSCOPIC STAPLER RELOAD WAS USED FOR PANCREATIC TRANSECTION IN 33 PATIENTS. THE ENDOSCOPIC STAPLER WAS USED FOR THE SPLENIC ARTERY AND VEIN IN PATIENTS UNDERGOING SPLENECTOMY. THERE WERE 3 CONVERSIONS TO OPEN SURGERY IN THE DPS GROUP DUE TO INTRAOPERATIVE BLEEDING FROM THE SPLENIC ARTERY. TRANSFUSION WAS NEEDED DUE TO THE INTRAOPERATIVE BLOOD LOSS. THERE WERE 15 POSTOPERATIVE PANCREATIC FISTULA (POPF) WITH 2 PATIENTS, 1 FROM EACH GROUP, THAT REQUIRED INTERVENTION. IN OTHER 13 PATIENTS WITH POPF, 3 WERE TREATED BY MAINTAINING THE SURGICAL DRAINAGE FOR LESS THAN 3 WEEKS; WHILE 7 AND 3 PATIENTS REQUIRED ENDOSCOPIC OR PERCUTANEOUS DRAINAGE, RESPECTIVELY. POSTOPERATIVE PANCREATIC HEMORRHAGE OCCURRED IN 3 PATIENTS IN THE DPS GROUP AND 1 IN THE SPDP GROUP. 2 REQUIRED REOPERATIONS; THE OTHER CASES WERE TREATED WITH PERCUTANEOUS DRAINAGE. THERE WAS 1 WOUND INFECTION AND 4 INTRAABDOMINAL ABSCESSES IN THE DPS GROUP. THERE WERE 6 AND 9 BIOCHEMICAL LEAKAGE IN THE DPS AND SPDF GROUP, RESPECTIVELY. THE LENGTH OF HOSPITAL STAY IN DPS GROUP WAS LONGER DUE TO THE HIGHER RATE POPF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886179 UNKNOWN EGIA TRI STAPLE STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN EGIA TRI STAPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention