BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VERSAPORT TROCAR

    MDR report key: 3833431 · Received May 20, 2014

    Report

    Report Number
    9612501-2014-00153
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP REPORT SENT TO FDA ON 10/10/2014.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: CUSTOMER REPORTS THAT THEY FOUND A .01MM X .01MM BLUE PLASTIC SHARD IN PATIENT DURING A SURGERY. IT WAS RETRIEVED AND PLACED IN SAMPLE CONTAINER LABELLED FOREIGN BODY WHICH IS BEING RETURNED FOR INVESTIGATION. HOWEVER, ALL ACTUAL SAMPLES USED DURING THE SURGERY WERE DISCARDED. CUSTOMER DOES NOT KNOW FROM WHICH OF THESE 4 ITEMS THE BLUE PLASTIC SHARD COULD HAVE BEEN FROM (175770 LOT J3H0087X; 179075P LOT J3M0448X, 179101 LOT J3K0873X, 179103P LOT J3F0048X). THERE WAS AN X-RAY DONE TO SEE IF THERE WAS A FRAGMENT OR COMPONENT LEFT IN THE PATIENT; RESULT UNKNOWN. NO INFORMATION RELATED TO PATIENT AVAILABLE. NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE OR BLEEDING. NO EXTENSION TO SURGICAL TIME REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298522 UNKNOWN VERSAPORT TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other