BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENEX HEALTH TX SYSTEM - MICROTIP

    MDR report key: 6854305 · Received September 11, 2017

    Report

    Report Number
    1000135560-2017-00133
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    May 25, 2017
    Report Date
    November 3, 2017
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR COMPLAINT EVALUATION. UPON RECEIPT AND EVALUATION OF THE DEVICE A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE (TX MICROTIP/HANDPIECE) FOR EVALUATION AND TESTING TO VERIFY THE REPORTED COMPLAINT OF BROKEN NEEDLE. VISUAL INSPECTION OF THE RETURNED DEVICE (TX MICROTIP) SHOWED THAT THE NEEDLE WAS INTACT, NOT BROKEN. THE TUBING CONNECTING TO THE HANDPIECE WAS CUT OFF AND SEPARATED FROM THE HANDPIECE. WE WERE UNABLE TO PERFORM FUNCTIONAL TESTING SINCE THE TUBING WAS CUT OFF. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT BASED ON THE EVALUATION OF THE RETURNED DEVICE AND HAVE NOTIFIED THE CLIENT THAT AN INCORRECT DEVICE COULD HAVE BEEN SENT FOR EVALUATION AS THE NEEDLE WAS INTACT. WE WILL SUBMIT A FOLLOW UP REPORT IF WE WERE TO RECEIVE THE ACTUAL DEVICE REPORTED AS "BROKEN NEEDLE"

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP (2ND) MDR REPORT IS TO CLARIFY THE PART/CATALOG NUMBER OF THE DEVICE RETURNED FOR EVALUATION. THE REPORTED COMPLAINT WAS FOR TX2 MICROTIP (PART NUMBER OF 554-2003-001 AND LOT NUMBER OF 06517-15); HOWEVER, THE DEVICE RETURNED FOR EVALUATION WAS VERIFIED TO BE TX1 MICROTIP WITH A PART NUMBER OF 554-1002-001. THE LOT NUMBER OF THE RETURNED DEVICE (TX1 MICROTIP) IS UNKNOWN. PLEASE IGNORE THE CATALOG NUMBER, LOT NUMBER, EXPIRATION DATE AND 510K NUMBER OF THE DEVICE REPORTED IN THE INITIAL MDR REPORT SENT. THE RELATED SECTIONS OF THIS FOLLOW UP (2ND) MDR REPORT IS UPDATED AS APPLICABLE BASED ON THE AVAILABLE INFORMATION. WE HAVE NOTIFIED THE CLIENT THAT THE REPORTED COMPLAINT WAS FOR TX2 MICROTIP (PART NUMBER OF 554-2003-001 AND LOT NUMBER OF 06517-15); HOWEVER, THE DEVICE RETURNED FOR EVALUATION WAS VERIFIED TO BE TX1 MICROTIP WITH A PART NUMBER OF 554-1002-001. AS WE INCLUDED IN THE 1ST FOLLOW UP MDR REPORT, THE NEEDLE RETURNED WAS INTACT, NOT BROKEN. WE WILL SUBMIT A FOLLOW UP REPORT IF WE WERE TO RECEIVE THE ACTUAL DEVICE INVOLVED IN THE INCIDENT.

    Description of Event or Problem · 1

    PER THE INFORMATION PROVIDED, TOWARD THE CONCLUSION OF THE PROCEDURE ON THE PATIENT'S GLUTEUS MEDIUS THE NEEDLE SEPARATED FROM THE HANDPIECE. THE NEEDLE REMAINED IN THE PATIENT WHEN THE HANDPIECE WAS REMOVED FROM THE PATIENT. THE DOCTOR RETRIEVED THE NEEDLE BY HAND. THERE WAS NO HARM, INJURY OR COMPLICATION TO THE PATIENT CAUSED BY THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636666 TENEX HEALTH TX SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other