BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 13153621 · Received January 4, 2022

    Report

    Report Number
    1219930-2022-00035
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    November 2, 2021
    Report Date
    January 4, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: PAIN VERSUS GAIN: MULTIPORT VERSUS SINGLE-PORT THORACOSCOPIC SURGERY FOR PEDIATRIC PNEUMOTHORAX A CASE SERIES SOURCE: INTERNATIONAL JOURNAL OF SURGERY OPEN VOLUME 37, DECEMBER 2021, 100428. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF SINGLE-PORT VERSUS MULTIPORT SURGICAL TECHNIQUE FOR VIDEO ASSISTED THORACOSCOPIC SURGERY IN PEDIATRIC PATIENTS (AGE 12-17) WITH PRIMARY SPONTANEOUS PNEUMOTHORAX BETWEEN AUGUST 2017 AND FEBRUARY 2021. THE STAPLER WITH 45-60 MM PURPLE TRI-STAPLE WAS USED TO RESECT THE REGION OF THE LUNG CONTAINING BLEBS. THERE WERE 7 PATIENTS IN THE STUDY AND ONE PATIENT EXPERIENCED THE COMPLICATION OF RECURRENT PNEUMOTHORAX REQUIRING REPLACEMENT OF CHEST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225633 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown Other