BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

    MDR report key: 17228683 · Received June 29, 2023

    Report

    Report Number
    3013479847-2023-00003
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    March 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, THE LOT NUMBER WAS NOT REPORTED AND THEREFORE A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. BLEEDING AND ASSOCIATED CONDITIONS SUCH AS HEMATOMA IS A KNOWN COMPLICATION FOR CTR SURGICAL PROCEDURES. FURTHERMORE, THE PHYSICIAN OF THIS CASE DID NOT IDENTIFY ANY DEVICE DEFICIENCY.

    Description of Event or Problem · 0

    A CARPAL TUNNEL RELEASE (CTR) PROCEDURE WAS PERFORMED ON A PATIENT WHO WAS ON AN ANTI-COAGULANT MEDICATION. THE PATIENT'S CARPAL TUNNEL SYMPTOMS BEGAN TO IMPROVE IMMEDIATELY FOLLOWING THE PROCEDURE. IN THE FEW DAYS FOLLOWING THE PROCEDURE THE PATIENT THEN DEVELOPED INCREASING PAIN AND NEUROLOGICAL SYMPTOMS AND SIGNS CONSISTENT WITH MEDIAN NERVE DYSFUNCTION AND WAS DIAGNOSED CLINICALLY WITH A PROBABLE HEMATOMA. A TRADITIONAL OPEN PROCEDURE WAS COMPLETED ON (B)(6) TO EXPLORE THE CARPAL TUNNEL, EVACUATE THE PRESUMED HEMATOMA, AND RELIEVE SYMPTOMS. NO ACTIVE BLEEDING VESSELS WERE IDENTIFIED, AND EXPLORATION OF THE MEDIAN NERVE AND ITS BRANCHES REVEALED NO INJURY. THE PATIENT'S NUMBNESS STARTED TO IMPROVE, AND SYMPTOMS WERE CONTINUING TO IMPROVE SLOWLY AS OF THE TIME THE PATIENT PASSED AWAY FROM UNRELATED MEDICAL ISSUES. THE PHYSICIAN DID NOT IDENTIFY ANY DEVICE DEFICIENCY. THE EXACT CAUSE OF THE HEMATOMA IS UNKNOWN, BUT THE PHYSICIAN BELIEVES THE BLEEDING MAY HAVE RESULTED FROM SMALL VESSELS IN THE CARPAL TUNNEL REGION AND THE PATIENT'S ANTICOAGULATED STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345012 ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE) CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention