BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REINFORCED RELOAD

    MDR report key: 13904894 · Received March 25, 2022

    Report

    Report Number
    1219930-2022-01051
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    May 7, 2021
    Report Date
    March 25, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: EFFICACY OF THE SLOW FIRING METHOD USING A REINFORCED TRIPLE-ROW STAPLER FOR PREVENTING POSTOPERATIVE PANCREATIC FISTULA DURING LAPAROSCOPIC DISTAL PANCREATECTOMY SOURCE: SURGERY TODAY (2022) 52:260¿267 PUBLISHED ONLINE: 28 JULY 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED THAT ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC DISTAL PANCREATECTOMY USING A SLOW FIRING METHOD BETWEEN JUNE 2014 AND OCTOBER 2020. PANCREATIC TRANSECTION WAS PERFORMED USING A REINFORCED RELOAD WITH TRI-STAPLES WITH THE BLACK CARTRIDGE. THE PANCREAS WAS SLOWLY COMPRESSED WITH THE STAPLER AT THE TRANSECTION SITE, AND THE JAWS OF THE STAPLER WERE CLOSED FOR 1¿3 MIN. AFTER CLOSING THE JAWS, THE PANCREAS WAS COMPRESSED FOR ANOTHER 3 MINUTES. THERE WERE 73 PATIENTS IN THE STUDY INCLUDING 50 PATIENTS WHO ALSO UNDERWENT SPLENECTOMY. COMPLICATIONS INCLUDED: POSTOPERATIVE PANCREATIC FISTULA, INTRA-ABDOMINAL ABSCESS AND POSTOPERATIVE HEMORRHAGE. REOPERATIONS AND READMISSIONS WERE REPORTED. THERE WERE 2 PATIENTS THAT WERE NOT INCLUDED IN THE STUDY BECAUSE PROCEDURE WAS CONVERTED TO AN OPEN HAND-SEWN PROCEDURE DUE TO STAPLING FAILURE RESULTING IN SEVERE DAMAGE TO THE PANCREATIC PARENCHYMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054826 UNKNOWN REINFORCED RELOAD STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN REINFORCED RELOAD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Required Intervention| H