BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH* TROCAR

    MDR report key: 2050372 · Received April 12, 2011

    Report

    Report Number
    3005075853-2011-01454
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEA
    PMA / PMN Number
    K920110
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT UPPER LOBECTOMY PROCEDURE, IT WAS FOUND THAT THE TIP OF THE SLEEVE WAS MISSING DURING USE. THE MISSING SIZE WAS ABOUT SEVEN MM TIMES SIX MM. THE DEVICE WAS USED AS A CAMERA PORT AND PLACED ON THE GLAND IN THE ARMPIT OF THE EIGHTH INTERCOSTAL SPACE. THE OPERATION WAS CONVERTED TO OPEN AND THE DOCTOR LOOKED FOR THE FRAGMENTS OF THE DEVICE. HOWEVER, NO FRAGMENTS WERE FOUND INSIDE THE PATIENT. THE DOCTOR HAS COMMENTED IT CANNOT BE DENIED THERE IS A POSSIBILITY THAT THE FRAGMENTS ARE INSIDE THE PATIENT AS OF NOW. THE DOCTOR ALSO COMMENTED THE DEVICE HAD BEEN RESTERILIZED TWICE, SO THE SLEEVE MIGHT HAVE BROKEN BEFORE THE OPERATION. UNKNOWN IF THERE WERE ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH* TROCAR GEA ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention