BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

    MDR report key: 15580294 · Received October 11, 2022

    Report

    Report Number
    3013479847-2022-00001
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    April 6, 2021
    Report Date
    October 11, 2022
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TENDON INJURIES ARE INCLUDED IN THE INSTRUCTION FOR USE AS A POSSIBLE COMPLICATION AS THE RESULT OF THE CARPAL TUNNEL RELEASE PROCEDURE. FURTHERMORE, THE PHYSICIAN OF THIS CASE INDICATED THAT THE DEVICE DID NOT MALFUNCTION, AND IT CAN BE CONCLUDED THAT THE DEVICE DID NOT LIKELY CAUSE THE INJURY DUE TO MALFUNCTION. 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

    POTENTIAL SEVERED TENDON. THE PHYSICIAN WAS INFORMED BY THE PATIENT THAT THE TENDON HAD BEEN SEVERED DURING THE PROCEDURE AND THE PATIENT WOULD NEED IT RECONSTRUCTED. NO INFORMATION WAS PROVIDED ON WHICH TENDON WAS SEVERED. THE PHYSICIAN INDICATED THE DEVICE DID NOT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482036 ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE) CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Disability