BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTONBLADE

    MDR report key: 7895867 · Received September 20, 2018

    Report

    Report Number
    3011394215-2018-00007
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    August 22, 2018
    Report Date
    August 22, 2018
    Manufacturer
    INVUITY, INC
    Product Code
    GEI
    UDI-DI
    00816728020639
    PMA / PMN Number
    K162053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT DEVICES WERE RECEIVED AND INVUITY ATTEMPTED TO REPLICATE THE DESCRIBED CLINICAL SETTING BASED ON INFORMATION PROVIDED BY THE HOSPITAL: TWO ESUS LOCATED NEAR THE HEAD OF THE BED, RELATIVE DEVICE HANDLE AND CABLE POSITIONS ALONG EACH SIDE OF THE BED. THE REPORTED BEHAVIOR COULD NOT BE REPRODUCED. FURTHER INVESTIGATION WAS PERFORMED IN AN ATTEMPT TO REPLICATE THE OBSERVATION WITH MORE AGGRESSIVE CONDITIONS, SUCH AS FLUID INGRESS, HIGHER ENERGY SETTINGS, AND INTENTIONALLY WRAPPING ONE CABLE ONTO THE OTHER DEVICE. THE REPORTED BEHAVIOR COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP TELEPHONE CONVERSATION WAS HELD WITH THE NURSE MANAGER THAT WAS INVOLVED IN THE CASE. THE PATIENT WAS RELEASED AS PLANNED; THERE WAS NO ADDITIONAL INTERVENTION OR EXTENDED STAY REQUIRED. THE PRODUCTS INVOLVED ARE UNDER EVALUATION WITH THE HOSPITAL AND ARE PLANNED TO BE RETURNED TO INVUITY FOR INVESTIGATION. ADDITIONALLY, THE HOSPITAL PERFORMED THEIR OWN INVESTIGATION AND HAS SINCE MODIFIED THEIR ESU SETUP WHEN USING TWO PHOTONBLADES IN THE SAME PROCEDURE.

    Description of Event or Problem · 1

    A BREAST MASTECTOMY/RECONSTRUCTION PROCEDURE UTILIZED TWO PHOTONBLADE DEVICES, WHICH WERE PERFORMING AS INTENDED. DURING THE MIDDLE OF THE PROCEDURE IT WAS REPORTED THAT ONE PHOTONBLADE DEVICE, WHEN ACTIVATED, WAS OBSERVED TO ACTIVATE THE SECONDARY PHOTONBLADE DEVICE. THE SECONDARY PHOTONBLADE WAS REPLACED WITH A NEW PHOTONBLADE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PHYSICIAN NOTICED A MINOR BURN NEAR THE AXILLA THAT REQUIRED A MINOR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734813 PHOTONBLADE PHOTONBLADE GEI INVUITY, INC PB1 18042001 00816728020639

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PHOTONBLADE (PB1) LOT 18052504 (EXP 25-MAY-2019)