BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 6108258 · Received November 16, 2016

    Report

    Report Number
    3009750704-2016-00024
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    September 9, 2016
    Report Date
    November 16, 2016
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER ON (B)(6) 2016 FOR THE REPORTED FAILURE, "ACOUSTICS DIDN'T SOUND RIGHT." VISUAL INSPECTION FOUND DEFORMATION OF THE CASE NOSE WITH A SMALL FRACTURE LINE INDICATING THAT SIDE LOAD PRESSURE HAD BEEN APPLIED TO THE HANDPIECE. THIS DAMAGE MAY HAVE CAUSED ALTERATION OF THE ACOUSTIC SIGNAL AS OBSERVED BY THE CUSTOMER. THE MICROTIP WAS RECEIVED WITH THE HANDPIECE CUT AWAY FROM THE TUBING AND CARTRIDGE. FULL FUNCTIONAL TESTING COULD NOT BE CONDUCTED DUE TO THE DAMAGED CONDITION OF THE DEVICE; HOWEVER, THE MICROTIP TUBING AND ELECTRICAL CONNECTIONS WERE JUMPED TAKE FUNCTIONAL MEASUREMENTS. THE DEVICE PRIMED ON THE FIRST ATTEMPT WITH THE TUBING JUMPED TOGETHER. THE EVALUATOR FOUND NO RESTRICTIONS IN REGARD TO FLUID FLOW THROUGH THE MICROTIP. THE LACK OF MELTING INDICATES PROPER FLUID FLOW AS THERE WAS NO OR MINIMAL HEAT BUILD-UP AT THE TIP. THEREFORE FLUID FLOW WAS NOT A CONTRIBUTING FACTOR TO THE VISUAL FAILURE. BASED UPON THE DAMAGE TO THE CASE NOSE, THE FAILURE WAS DETERMINED TO BE CAUSED BY EXCESSIVE OR SIDE LOAD PRESSURES APPLIED TO THE MICROTIP (AGGRESSIVE TECHNIQUE).

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED OF A DEVICE FAILURE ON SEPTEMBER 9, 2016. THE COMPLAINANT REPORTED THAT THE DOCTOR STATED THE ACOUSTICS DID NOT SOUND RIGHT SO HE SWITCHED TO A DIFFERENT HANDPIECE TO FINISH. THE MICROTIP WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6) 2016. DURING VISUAL INSPECTION OF THE DEVICE, A SMALL FRACTURE LINE WAS FOUND IN THE CASE NOSE (NOSE CONE). AS THERE WAS A FRACTURE OF THE POLYCARBONATE THIS WAS DETERMINED TO BE A REPORTABLE EVENT. FRACTURING HAS THE POTENTIAL FOR POLYCARBONATE PARTICULATE TO BE LEFT BEHIND IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757452 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 12716-03

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other