BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

    MDR report key: 17393265 · Received July 25, 2023

    Report

    Report Number
    3013479847-2023-00004
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 25, 2023
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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. INFECTION IS REFERENCED IN THE ULTRAGUIDECTR INSTRUCTIONS FOR USE AS A POSSIBLE COMPLICATION. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 0

    THE PATIENT DEVELOPED A DEEP INFECTION FOLLOWING A UNILATERAL RELEASE CTR-US PROCEDURE. THE PROCEDURE WAS ON (B)(6)2023. PROPHYLACTIC ANTIBIOTICS WERE NOT ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS REPORTED TO BE DOING WELL 2-3 DAYS FOLLOWING THE PROCEDURE. THE WOUND HAD HEALED, AND THE PATIENT WAS PROGRESSING AS USUAL. THE PATIENT RETURNED TO WORK ON (B)(6)2023, BUT REPORTED SORENESS ON THE FOLLOWING DAY. SYMPTOMS WERE PERSISTENT AND WORSENING THROUGH (B)(6) 2023. THE PATIENT WAS PLACED ON ORAL KEFLEX AND EVALUATED ON (B)(6) 2023. THE PHYSICIAN NOTED DRAINAGE FROM THE WOUND, WHICH HAD OPENED, AS WELL AS SWELLING AT THE INCISION SITE AND SMALL FINGER AND TOOK THE PATIENT BACK TO THE OR FOR SURGICAL IRRIGATION AND DEBRIDEMENT. UPON OPENING THE INCISION, THE PHYSICIAN SAW PUS/PURULENCE, WHICH WAS REMOVED AND WASHED OUT. UPON INCISING THE SMALL FINGER A1 PULLEY, PUS WAS ALSO ENCOUNTERED AND WASHED OUT. UPON OPENING THE RING FINGER A1 THE PHYSICIAN DID NOT ENCOUNTER ANYTHING AND THEREFORE CONCLUDED THAT THIS WAS A DEEP INFECTION IN THE CARPAL TUNNEL THAT HAD SPREAD TO THE SMALL FINGER FLEXOR TENDON. THERE WERE NO OTHER ANATOMIC FINDINGS. THE PATIENT WAS DOING WELL ON (B)(6) 2023. IT WAS REPORTED THE INFECTION HAD CLEARED UP NICELY. NO DEVICE MALFUNCTION WAS REPORTED. THE PATIENT HAD INFORMED THE PHYSICIAN THAT IT IS POSSIBLE THEY MAY HAVE CAUSED THE INFECTION BY INJURING OR ABRADING THEIR HAND OVER THE INCISION SITE UPON RETURNING TO WORK FOLLOWING THE CTR-US PROCEDURE. IT WAS UNKNOWN WHETHER THE PATIENT COVERED THE INCISION SITE WHILE AT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635270 ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE) CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention