BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX1 TISSUE REMOVAL SYSTEM

    MDR report key: 3129909 · Received May 22, 2013

    Report

    Report Number
    2085033-2013-00001
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE BACKING THE HANDPIECE OUT FROM THE SURGICAL SITE, THE DOCTOR NOTICED THE NEEDLE HAD SEPARATED FROM THE DEVICE. THE DOCTOR PUSHED THE HANDPIECE FORWARD AND RETRACTED THE NEEDLE WITH THE DEVICE. NO LOT INFORMATION FOR THE HANDPIECE COULD BE PROVIDED BY THE FACILITY. THE LOT NUMBER LISTED IN SECTION D4 IS FOR THE CONVENIENCE KIT SUPPLIED IN THE PRODUCT. CONVENIENCE KIT LOT NUMBER 07813-15 WAS DISTRIBUTED WITH TX1 TISSUE REMOVAL SYSTEM LOT NUMBER 07713-18 AND LOT NUMBER 08113-04. THE LOTS WERE RELEASED TO INVENTORY 04/01/2013 AND EXPIRE 02/2014. A REVIEW OF THE DHR'S DO NOT SUGGEST A MANUFACTURING PROBLEM. A REVIEW OF COMPLAINTS FOR THE APPLICABLE MANUFACTURED LOTS INDICATE NO OTHER BREAKAGE OR SEPARATION. MORE THAN THREE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO GET INFORMATION DIRECTLY FROM THE DOCTOR. THERE IS NO CONFIRMATION AS TO HOW THE DEVICE WAS USED PRIOR TO THE SEPARATION (I.E.: AGGRESSIVE BEHAVIOR, OFF-LABEL USAGE). AN INTERNAL VALIDATION WAS DONE INDICATING THAT THE TIP WILL BREAK IF USED UNDER EXTREME CONDITIONS SUCH AS USAGE THAT WOULD CAUSE SIDE LOADING FORCE TO BE APPLIED (OUR REPORT (B)(4)).

    Description of Event or Problem · 1

    MICROTIP DISLODGED FROM DILATOR AND REMAINED IN TISSUE AS HAND PIECE WAS REMOVED. WAS EASILY REMOVED AND DID NOT HARM PATIENT. WE ARE VERY CONCERNED THAT IT MIGHT HAPPEN AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227781 TX1 TISSUE REMOVAL SYSTEM ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 07813-15

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention