BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOGIA

    MDR report key: 7645675 · Received June 28, 2018

    Report

    Report Number
    2647580-2018-03200
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    June 12, 2018
    Report Date
    July 11, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: (INTERVENTION REQ). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING WEDGE CUTTING ON A LAPAROSCOPIC PNEUMOTHORAX SURGERY, THE DEVICE BURST NAILS AND ONE CAN NOT BE FIRED. THEY HAD TO MANUALLY SUTURE TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING WEDGE CUTTING ON A LAPAROSCOPIC PNEUMOTHORAX SURGERY, THE DEVICE BURST NAILS AND ONE CAN NOT BE FIRED. THEY HAD TO MANUALLY SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487849 ENDOGIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN ENDO GI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention