BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS FOCUS 9CM PLUS ADAPTIVE

    MDR report key: 8084456 · Received November 19, 2018

    Report

    Report Number
    3005075853-2018-14439
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    January 18, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014669
    PMA / PMN Number
    K132612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: JJM REP ADVISED THAT SHE DID FOLLOW UP WITH SURGEON AND ALL HE ADVISED IS THAT POST-OP WAS AS PER USUAL, THE THERMAL BURN IS MINOR AND ONLY PUT ON A DRESSING TO WOUND. NO OTHER INFORMATION PROVIDED. FROM THE SURGEON'S DESCRIPTION OF THE EVENT, IT WAS NOT LONG AFTER ACTIVATION THAT THE DEVICE THEN RESTED ON THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS COMPLETING AN AXILLARY CLEARANCE PROCEDURE WITH THE REGISTRAR, WHILE UTILIZING THE FOCUS+ DEVICE WHEN NEEDED, THE REGISTRAR RESTED THE DEVICE ON THE PATIENTS ARM AT POINTS DURING THE PROCEDURE AND THERE WAS A THIRD DEGREE BURN TO THE PATIENT. THE BURN WAS TREATED WITH A DRESSING AND THEY ARE UNSURE IF THERE WILL BE ANY LONG TERM EFFECTS FROM THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923354 HS FOCUS 9CM PLUS ADAPTIVE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. P4T15F 10705036014669

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GENERATOR AND HANDPIECE