BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - CONSOLE

    MDR report key: 5728142 · Received June 15, 2016

    Report

    Report Number
    3009750704-2016-00006
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 15, 2016
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSOLE SERIAL NUMBER (B)(4) WAS RETURNED TO THE MANUFACTURER IN CONJUNCTION WITH THE THREE MICROTIPS FROM THE SAME CASE. EVALUATION OF THE MICROTIPS FOUND NO DEFICIENCY OR FAILURE (EVALUATION RESULTS BELOW), THEREFORE, BASED UPON THE INVESTIGATION THE FAILURE WAS DETERMINED TO BE CAUSED BY THE CONSOLE. EVALUATION OF THE CONSOLE FOUND THAT THE COAGULATION WAS NOT FUNCTIONING (THE COAGULATION CONNECTOR ASSEMBLY WIRES HAD BEEN PULLED LOOSE FROM THE CONNECTOR "BUCKET") AND THE TOUCHSCREEN WAS NOT RESPONDING CORRECTLY TO INPUT. TO CONTINUE THE EVALUATION, THE CONSOLE THE COAGULATION CONNECTOR ASSEMBLY AND THE LCD TOUCHSCREEN WERE REPAIRED. FURTHER TESTING/ EVALUATION FOUND RUST IN THE FOUR (4) BEARING SCREWS AND FOUR (4) ROLLER BEARINGS ON THE SIDE PLATE ASSEMBLY. IN ADDITION, THE FORCE SENSOR SHOWED SIGNS OF A FLUID LEAK. THE RUST IN THE SIDE PLATE AND A WET FORCE SENSOR WOULD IMPACT THE FUNCTIONALITY OF THE CONSOLE RESULTING IN THE REPORTED FAILURES - "STOPPED CUTTING" AND "FLUID PATH BLOCKED." THE REPORTED FAILURES COULD NOT BE DUPLICATED, HOWEVER EVALUATION OF THE CONSOLE INDICATES IT IS HIGHLY PROBABLE THAT THE CONSOLE CAUSED/ CONTRIBUTED TO THE REPORTED FAILURES. PER THE INFORMATION PROVIDED, THERE WAS NO HARM, INJURY OR COMPLICATION TO THE PATIENT DUE TO THE FAILURE. THE DOCTOR WAS ABLE TO COMPLETE THE LEFT PERONEAL TENDON WITH THE ORIGINAL MICROTIP. DUE TO THE CONSOLE FAILURE, THE PROCEDURE ON THE RIGHT FOOT WAS CONVERTED TO DRY NEEDLING. PER THE MANUFACTURER'S POLICY A FAILURE OF THE MANUFACTURER'S DEVICE RESULTING IN A CONVERGENT SURGERY, AFTER THE PATIENT HAS BEEN PREPARED FOR SURGERY, IS REPORTABLE. THE CAUSE OF THE FAILURE WAS DETERMINED TO BE THE CONSOLE, THEREFORE AN MDR WAS FILED ON THE FAILED DEVICE. THE CONSOLE IS INTENDED FOR MULTIPLE USES AND DRIVES THE ONE-TIME USE MICROTIP. MICROTIP #1 EVALUATION (LOT# 11216-01): THE MICROTIP ASSEMBLY ARRIVED WITH THE PERISTALTIC TUBING MISALIGNED. THE TUBING WAS REALIGNED FOR FUNCTIONAL TESTING. NO OTHER DAMAGE OR DEFECT OBSERVED. THE MICROTIP PRIMED ON THE FIRST ATTEMPT AND COMPLETED 2.5 MINUTES OF FUNCTIONAL TESTING WITHOUT ISSUE. DURING SIMULATION TESTING, THE MICROTIP ASSEMBLY PRIMED ON THE FIRST ATTEMPT AND THEN COMPLETED 12 MINUTES OF TESTING WITHOUT ISSUE. THE REPORTED FAILURE COULD NOT BE DUPLICATED. EVALUATION OF THE CONSOLE INDICATED THE POTENTIAL FOR A CARTRIDGE LATCH FAILURE DUE TO RUST. THE PRESENCE OF RUST INDICATED THAT THE SIDE PLATE ASSEMBLY HAD BEEN WET. FLUID ON THE FORCE SENSOR WIRING ASSEMBLY CAN CAUSE TEMPORARY FAILURES SUCH AS "STOPPED CUTTING" OR "FLUID PATH BLOCKED." MICROTIP #2 EVALUATION (LOT# 11216-01): NO DAMAGE OR DEFECT NOTED DURING VISUAL EXAMINATION. THE MICROTIP PRIMED SUCCESSFULLY ON THE FIRST ATTEMPT AND COMPLETED 1 MINUTE OF FUNCTIONAL TESTING WITHOUT ISSUE. DURING SIMULATION TESTING, THE MICROTIP ASSEMBLY PRIMED ON THE FIRST ATTEMPT AND THEN COMPLETED 12 MINUTES OF TESTING WITHOUT ISSUE. THE REPORTED FAILURE OF "FLUID PATH BLOCKED" COULD NOT BE DUPLICATED. EVALUATION OF THE CONSOLE INDICATED THE POTENTIAL FOR A CARTRIDGE LATCH FAILURE DUE TO RUST. THE PRESENCE OF RUST INDICATED THAT THE SIDE PLATE ASSEMBLY HAD BEEN WET. FLUID ON THE FORCE SENSOR WIRING ASSEMBLY CAN CAUSE TEMPORARY FAILURES SUCH AS "STOPPED CUTTING" OR "FLUID PATH BLOCKED." THE FAILURES SUBSIDE ONCE THE FORCE SENSOR IS DRY. MICROTIP #3 EVALUATION (LOT# 11216-01): NO FLUID WAS OBSERVED IN THE TUBING OR COLLECTION BAG INDICATING THAT THE PRIMING CYCLE NEVER INITIATED. THE MICROTIP PRIMED SUCCESSFULLY ON THE FIRST ATTEMPT AND COMPLETED 1 MINUTE OF FUNCTIONAL TESTING WITHOUT ISSUE. DURING SIMULATION TESTING, THE MICROTIP ASSEMBLY PRIMED ON THE FIRST ATTEMPT AND THEN COMPLETED 12 MINUTES OF TESTING WITHOUT ISSUE. THE REPORTED FAILURE OF "FLUID PATH BLOCKED" COULD NOT BE DUPLICATED. EVALUATION OF THE CONSOLE INDICATED THE POTENTIAL FOR A CARTRIDGE LATCH FAILURE DUE TO RUST. THE PRESENCE OF RUST INDICATED THAT THE SIDE PLATE ASSEMBLY HAD BEEN WET. FLUID ON THE FORCE SENSOR WIRING ASSEMBLY CAN CAUSE TEMPORARY FAILURES SUCH AS "STOPPED CUTTING" OR "FLUID PATH BLOCKED."

    Description of Event or Problem · 1

    PER THE COMPLAINT REPORTER, THE FIRST MICROTIP LOST THE AUDIBLE CUTTING SIGNAL AT 2:30 MINUTES CUTTING TIME. UNPLUGGED AND PLUGGED IN THE MICROTIP POWER CONNECTION SEVERAL TIMES. UNABLE TO HEAR AUDIBLE CUTTING SIGNAL. REPLACED AND PRIMED SECOND HANDPIECE - ERROR: FLUID PATH BLOCKED. TRIED TO REPRIME SEVERAL TIMES WITH SAME ERROR CODE APPEARING. OPENED THIRD MICROTIP, REPLACED SALINE WITH NEW BAG, PRIMED AND GOT SAME ERROR: FLUID PATH BLOCKED. ATTEMPTED SEVERAL RE-PRIMINGS WITHOUT SUCCESS. LEFT PERONEAL TENDONS COMPLETED, PHYSICIAN OPTED TO DRY NEEDLE RIGHT PERONEAL TENDONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379590 TX1 TISSUE REMOVAL SYSTEM - CONSOLE ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH 554-0000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR