BEUDAMED
    FDA Adverse Event Summary report: N

    BLADELESS VP 8MM ST W/ FIXATION

    MDR report key: 4180406 · Received October 17, 2014

    Report

    Report Number
    9612501-2014-00316
    Date Received
    October 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC TUBAL LIGATION. ACCORDING TO THE REPORTER: PART OF THE NON-BLADED OBTURATOR INSERTION TIP BROKE OFF. THE PIECE WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663368 BLADELESS VP 8MM ST W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1