BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 3-0 30 VIOLET CV-25 P/O

    MDR report key: 3855158 · Received May 29, 2014

    Report

    Report Number
    1219930-2014-00411
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: RADICAL RESECTION OF PULMONARY. CARCINOMA UNDER THORACOSCOPE. ACCORDING TO THE REPORTER: THE DOCTOR USED GL182M TO SUTURE TISSUES UNDER THE ENDOSCOPE AND FOUND THE NEEDLE TIP WAS MISSING ON THE SUTURE. THE TIP OF THE NEEDLE COULD HAVE FALLEN INTO THE PT CAVITY, HOWEVER THE DOCTOR IS NOT SURE WHETHER THE TIP OF THE NEEDLE IS IN THE PT'S BODY. THERE'S NO SUSPECTED TIP IN THE POSTOPERATIVE CHEST RADIOGRAPH. THERE WAS NO BLEEDING OF 500CC OR MORE? THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THE PROCEDURE WAS NOT CONVERTED TO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317374 POLYSORB 3-0 30 VIOLET CV-25 P/O POLYSORB SUTURE GAM COVIDIEN, FORMERLY US SURGICAL B2E0491X

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other