MAUDE Adverse Event Report: BRAINLAB AG EXACTRAC DYNAMIC (VERSION 1.1); ACCELERATOR, LINEAR, MEDICAL, PRODUCT CODE: IYE

Model Number 48519A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

B2, h1: a risk to the patients' health could not be excluded for these specific circumstances, since patients were not positioned as intended for radiation therapy with exactrac dynamic involved, and thus radiation not applied exactly in the intended location, although according to the hospital: despite dose was applied incorrectly (to incorrect target compared to the intended dose distribution).There was no overdose, esp.None that would exceed clinically acceptable limits for the specific treatments; also potential under-dose remained clinically acceptable.There was no negative clinical effect to the specific patients, neither occurred nor expected.There were no remedial actions done, planned or necessary for the specific patients/treatments due to the dose not applied in accordance with the treatment plan (on basis of the dosimetric estimation performed, the doctor decided not to repeat the dosimetry and to favor the continuity of the treatment).The (overall) treatments could/can be completed successfully.H6: according to the results of the technical investigation and the information provided by the hospital, it can be concluded that the root cause for six patients not positioned as intended for radiotherapy treatment (distance from isocenter 10.22 mm acc.To log file analysis) is: an incorrect calibration of exactrac dynamic due to the calibration phantom positioned incorrectly for calibration (not placed sufficiently close to the isocenter as required for the calibration procedure to perform an accurate system calibration).Apparently the deviation between the isocenter of exactrac dynamic stored during the calibration step and the actual linac isocenter was not recognized by the user before performing patient treatments, since a radiation isocenter calibration had not been performed, and the execution of the daily check did not comply with the instructions.Brainlab highly recommends a radiation isocenter calibration to be performed after the isocenter calibration for best treatment accuracy.If this had been done, the deviation between calibrated isocenter and radiation isocenter would have been displayed on the exactrac dynamic screen (the threshold for this message box to be displayed is 1.0 mm deviation).Additionally, verification of calibration accuracy was not performed as required: the daily check workflow was started, but the required visual confirmation of the phantom marks matching the room lasers was not performed.There is no indication of a systematic error or malfunction of the brainlab device (exactrac dynamic).Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.H7: corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.Additionally, brainlab intends to offer a general product training to users a this customer site.Note that the exactrac dynamic system was correctly calibrated on the evening of (b)(6) 2023.

Event Description

The user detected on the evening of (b)(6) 2023 that the exactrac dynamic system they had used to treat patients during the day had been incorrectly calibrated on the morning of that same day.The incorrect calibration led to a deviation of patient positioning (distance from isocenter 10.22 mm), and 6 patient treatments were affected (5 treatments of glioblastoma, 1 stereotactic radiosurgery treatment of the operating cavity after excision of secondary vermian lesion of colon carcinoma).The system was correctly calibrated by the user on the evening of (b)(6) 2023.According to the hospital/physicist: despite dose was applied incorrectly (to incorrect target compared to the intended dose distribution).There was no overdose, esp.None that would exceed clinically acceptable limits for the specific treatments; also potential under-dose remained clinically acceptable there was no negative clinical effect to the specific patients, neither occurred nor expected.There were no remedial actions done, planned or necessary for the specific patients/treatments due to the dose not applied in accordance with the treatment plan (on basis of the dosimetric estimation performed, the doctor decided not to repeat the dosimetry and to favor the continuity of the treatment).The (overall) treatments could/can be completed successfully.

• Brand Name: EXACTRAC DYNAMIC (VERSION 1.1)
• Type of Device: ACCELERATOR, LINEAR, MEDICAL, PRODUCT CODE: IYE
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 17395264
• MDR Text Key: 319926636
• Report Number: 8043933-2023-00055
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 04056481143978
• UDI-Public: 04056481143978
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K231052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48519A
• Device Catalogue Number: 20910-01F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other