BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 11768213 · Received May 4, 2021

    Report

    Report Number
    1219930-2021-01751
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    August 13, 2020
    Report Date
    May 4, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521191013
    PMA / PMN Number
    K133938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: UTILITY OF THE POWERED STAPLER FOR RADICAL PULMONARY RESECTION: A PROPENSITY SCORE-MATCHED ANALYSIS SOURCE: RECEIVED: 13 APRIL 2020 / ACCEPTED: 13 AUGUST 2020 / PUBLISHED ONLINE: 9 OCTOBER 2020 / HTTPS://DOI.ORG/10.1007/S00595-020-02154-9. (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, (YEAR JANUARY 2016 AND DECEMBER 2019) THIS STUDY AIMED TO ASSESS THE OUTCOME OF A UTILITY OF A POWERED STAPLER WITH THAT OF A MANUAL STAPLER IN PATIENTS UNDERGOING PULMONARY RESECTION. IT IS NOTED THAT PULMONARY RESECTION WAS ACCOMPLISHED USING THE POWERED STAPLING SYSTEM OR A MANUAL STAPLER. THERE WERE 448 PATIENTS INCLUDED IN THE STUDY (179 USED POWERED STAPLER AND 269 USED MANUAL STAPLER). A TOTAL OF 28 PATIENT HAD A POST OPERATIVE AIR LEAKS (5 ON POWERED STAPLER AND 23 ON THE MANUAL STAPLER. IT WAS NOTED THAT FIBRIN GLUE WAS APPLIED INTRA-OPERATIVELY IF THE AIR LEAK WAS IDENTIFIED PRIOR TO WOUND CLOSURE. ADDITIONALLY, THE PRESENCE OF AN AIR LEAK RESULTED IN PROLONGED CHEST TUBE INSERTION AS WELL AS THE NEED FOR ADDITIONAL CHEST X-RAYS POST-OPERATIVELY AND PROLONGED HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664549 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIATRS60AMT 10884521191013

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention