BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

    MDR report key: 15580287 · Received October 11, 2022

    Report

    Report Number
    3013479847-2022-00002
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    February 3, 2022
    Report Date
    October 11, 2022
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DAMAGED NERVES DURING CARPAL TUNNEL RELEASE COULD CAUSE PERMANENT IMPAIRMENT OF THE HAND FUNCTION, OR CHRONIC PAIN. IT IS UNCLEAR IF THIS OCCURRED WITH THIS EVENT BASED ON THE INFORMATION PROVIDED. THE INSTRUCTION FOR USE INDICATES "INJURY TO NERVES " AS A POTENTIAL COMPLICATION. IT IS UNKNOWN IF THIS PATIENT REQUIRED AN ADDITIONAL SURGICAL INTERVENTION TO PREVENT PERMANENT DAMAGE. THE REPORTED EVENT DATE IS AN APPROXIMATE DATE OF THE EVENT. 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.

    Description of Event or Problem · 0

    THE PHYSICIAN INDICATED THAT HE HAD A PATIENT WITH A POTENTIAL NERVE INJURY. PER THE PHYSICIAN, THERE WAS CONTRACTURE POST PROCEDURE/POTENTIAL NERVE INJURY. IMAGING WAS COMPLETED AND NERVE DAMAGE WAS NOT SEEN IN THE IMAGES, BUT THE PATIENT WAS REFERRED TO A HAND SURGEON. THERE WAS NO DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482029 ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE) CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability