BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCENTRA BRACHY

    MDR report key: 12613703 · Received October 12, 2021

    Report

    Report Number
    9611894-2021-00002
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    August 2, 2021
    Report Date
    January 4, 2022
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    UDI-DI
    08717213052314
    PMA / PMN Number
    K132816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10 ADDITIONAL INFORMATION. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER INADVERTENTLY SELECTED THE INCORRECT RECONSTRUCTION DIRECTION IN ONCENTRA BRACHY WHILE PRACTICING TREATMENT PLANNING. THE CUSTOMER IS WORKING WITH ONCENTRA BRACHY VERSION 4.5.3 IN WHICH THE LAST SELECTED RECONSTRUCTION DIRECTION WILL BE SELECTED AUTOMATICALLY WHEN CREATING A NEW PLAN. IN ADDITION, THE USER MANUAL INFORMS THE USER OF AN 'INDEPENDENT VISUAL CHECK' ON 'CORRECT IMPLANT/INDIVIDUAL CATHETER GEOMETRY (IN IMAGE VIEW AND/OR 3D VIEW)' THAT NEEDS TO BE PERFORMED TO VERIFY THE CORRECTNESS OF THE CATHETER RECONSTRUCTION. THE CUSTOMER HAS INFORMED ELEKTA THAT THEY HAVE IMPLEMENTED A PEER REVIEW STEP IN THEIR LOCAL TREATMENT PLANNING PROCEDURE TO PREVENT RECURRENCE OF THE ISSUE. THE PRODUCT IS WORKING AS DESIGNED AND INTENDED. THE ROOT CAUSE FOR THIS ISSUE WAS DETERMINED TO BE USE ERROR. THE HOSPITAL CONFIRMED TO ELEKTA THAT THERE WAS NO SERIOUS INJURY FROM THE PATIENTS' SKIN ADVERSE REACTIONS.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED POSSIBLE CATHETER RECONSTRUCTION ISSUE WITH SAVI PLANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509989 ONCENTRA BRACHY SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED JAQ NUCLETRON B.V. 170003-28 08717213052314
    1509998 ONCENTRA BRACHY SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED JAQ NUCLETRON B.V. 170003-28 08717213052314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown