BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

    MDR report key: 15658644 · Received October 24, 2022

    Report

    Report Number
    3013479847-2022-00004
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    May 1, 2018
    Report Date
    October 21, 2022
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE INSTRUCTION FOR USE INDICATES "INJURY TO NERVES " AS A POTENTIAL COMPLICATION. THE PHYSICIAN INDICATED THE PATIENT MOVED SUDDENLY DURING THE INITIAL CTR PROCEDURE, AND THAT HE DETECTED THE INJURY DURING A FOLLOW-UP AND PERFORMED A REPAIR. HE SUSPECTED DECREASED SENSATION ON THE RADIAL ASPECT OF THE RING FINGER (IN THE TERRITORY OF THE 3RD COMMON PALMAR DIGITAL NERVE) AFTER FOLLOW-UP TREATMENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INSTRUCTIONS FOR USE STATES THE PRECAUTION THAT THE POSITION OF THE PATIENT'S HAND SHOULD BE CONTROLLED DURING THE PROCEDURE. UNWANTED HAND MOVEMENT MAY MAKE THE PROCEDURE MORE DIFFICULT OR RESULT IN INJURY.

    Description of Event or Problem · 0

    POTENTIAL NICKED NERVE. THE PHYSICIAN REPORTED THAT DURING A PREVIOUS SURGERY THE PATIENT MOVED THEIR ARM WHILE THE DEVICE WAS INSERTED IN THE ARM AND THE BLADE NICKED A NERVE. NO REPORTED DEVICE MALFUNCTION. HE DETECTED A POTENTIAL ISSUE IN THE EARLY POST-OPERATIVE PERIOD, AT WHICH TIME HE SUSPECTED A POTENTIAL INJURY TO THE 3RD COMMON PALMAR DIGITAL NERVE. HE EXPLORED THE NERVE, DOCUMENTED A PARTIAL LACERATION OF THE 3RD COMMON PALMAR DIGITAL NERVE, AND REPAIRED AND WRAPPED IT WITH A NERVE WRAP. THE PHYSICIAN INDICATED THAT THE PATIENT'S EARLY POST-OPERATIVE RECOVERY FOLLOWING THE REPAIR AND WRAP WAS UNEVENTFUL, BUT THE PATIENT WAS LOST TO FOLLOW-UP THEREAFTER BECAUSE HE MOVED OUT OF THE AREA. CONSEQUENTLY, THE ULTIMATE OUTCOME WAS UNKNOWN. THE PHYSICIAN INDICATED THAT HE SUSPECTED THE PATIENT WOULD HAVE HAD SOME DECREASED SENSATION ON THE RADIAL ASPECT OF THE RING FINGER (IN THE TERRITORY OF THE 3RD COMMON PALMAR DIGITAL NERVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820690 ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE) CARPAL TUNNEL RELEASE SYSTEM, LXH SONEX HEALTH 600112-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| S