BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CLIPGUN

    MDR report key: 4233548 · Received November 6, 2014

    Report

    Report Number
    2021898-2014-00439
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    EMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A CLIP WAS INADVERTANTLY LEFT IN THE PATIENT. IT WAS INCIDENTALLY DISCOVERED IN A SUBSEQUENT OPERATION AT ANOTHER HOSPITAL. IT WAS ALSO REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715776 UNKNOWN CLIPGUN HEMOSTAT, SURGICAL EMD MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other