BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 11667890 · Received April 14, 2021

    Report

    Report Number
    1000135560-2021-00029
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    February 14, 2018
    Report Date
    April 14, 2021
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006154
    PMA / PMN Number
    K153299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE OR TREATMENT COMPLICATIONS WERE NOTED DURING THE PROCEDURE. THE PHYSICIAN SAW THE PATIENT EVERY 2 WEEKS POST-PROCEDURE FOR FOLLOW-UP. THE PLANTAR FASCIA WAS IMPROVING EACH TIME. ON THE 3RD VISIT (5-6 WEEKS POST-OP), THE PATIENT REPORTED PAIN IN THE FOOT NEAR THE TREATMENT AREA. THE AREA WAS IMAGED. A PIECE OF METAL WAS IDENTIFIED IN THE FAT LAYER NEARBY AND REMOVED PERCUTANEOUSLY DURING THE VISIT WITHOUT ISSUE. THE METAL PIECE WAS APPARENTLY A SECTION OF THE NEEDLE FROM THE MICROTIP USED DURING THE EARLIER TX PROCEDURE. DUE TO THE LINGERING NEUROPATHY ON EITHER SIDE OF THE FOOT (AND OTHER AREAS OF THE BODY) THAT PRESENTED PRIOR TO THE TX PROCEDURE AND REMAINED AFTER FOLLOW-UP, THE PATIENT WAS REFERRED TO NEUROLOGY AT THE 3RD FOLLOW-UP VISIT. THE PHYSICIAN DID NOT THINK THE NEUROPATHY WAS RELATED TO THE PLANTAR FASCIA TREATMENT OR TX DEVICE.

    Description of Event or Problem · 1

    THERE WAS A NEEDLE BREAK AND RETAINED NEEDLE FRAGMENT DURING A PLANTAR FASCIA PROCEDURE. THE PLANTAR FASCIA TREATMENT WAS SUCCESSFUL. THE NEEDLE PIECE WAS LATER IDENTIFIED IN NEARBY FATTY TISSUE AND REMOVED PERCUTANEOUSLY WITHOUT INCIDENT DURING A POST-OP FOLLOW-UP VISIT. NO PERIPHERAL INJURY OR COMPLICATIONS RELATED TO THE NEEDLE RETENTION AND REMOVAL WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564923 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 NI 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other