MAUDE Adverse Event Report: BRAINLAB AG EXACTRAC 6.2; PATIENT POSITIONING SYSTEM, RADIATION THERAPY

Model Number	48355
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Human Factors Issue (2948); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A risk to patient's health could not be excluded for this specific circumstance since in this specific case 2 patients were irradiated in a position other than intended and the 3rd patient would have been if exactrac 6.2.0 positioning had been used, although: - there is no indication of an error or malfunction of the brainlab device.- the corresponding measures to minimize this anticipated risk to be as low as reasonably practicable are already in place.- no negative clinical effects to the patients were reported due to this issue.According to the results of brainlab investigation, the root cause for the incorrect patient position is user error during the first calibration of exactrac 6.2.0 in the morning of 4 may 2017.Investigation of the provided patient data, log files and software system (ini) files containing the calibration data of the exactrac 6.2.0 system revealed that in the morning before the treatment of the three patients, the user performed an exactrac infrared and x-ray system calibration to define the isocenter.The user was warned by the software that the isocenter he/she was about to define was significantly different from the previously stored isocenter.Exactrac was calibrated by the user to an isocenter deviating by approximately 11 mm in vertical direction from the room laser crossing.There is no indication of a malfunction or quality or performance issue with the brainlab device.According brainlab measures to minimize this anticipated risk to be as low as reasonably practicable are already in place.Brainlab intends to: - inform this hospital about the investigation results - offer an additional training to users at this hospital.Device not available for evaluation.
Event or Problem Description
The hospital informed brainlab that on a single day, the user performed radiotherapy treatment of three patients.Prior to the patient treatment, the brainlab exactrac 6.2.0 device was calibrated by the user to an isocenter deviating by approximately 11 mm in vertical direction from the room laser crossing.The user placed manual markings where the room laser was expected to land.For all three patients, the markings did not match well to the lasers when the patient was positioned with exactrac 6.2.0.Patient 1 and patient 2 were treated in the position reached using exactrac 6.2.0, despite awareness by the user that the markings did not match the room lasers.Therefore the positioning with exactrac 6.2.0 resulted in an incorrect treatment position approximately 11 mm below the correct treatment position for these patients.For patient 3, the user reportedly became more concerned when the deviation was again visible, as it was consistently appearing for each patient that day.The user decided to verify the treatment position before treatment of patient 3 with the non-brainlab varian kv imaging, and discovered a discrepancy between the exactrac 6.2.0 position and the intended treatment position.The user did not position patient 3 with exactrac 6.2.0.The user instead positioned this patient according to the non-brainlab varian kv device.No negative clinical effects to the patients were reported due to this issue.

• Brand Name: EXACTRAC 6.2
• Common Device Name: PATIENT POSITIONING SYSTEM, RADIATION THERAPY
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• MDR Report Key: 6607682
• Report Number: 8043933-2017-00012
• Device Sequence Number: 13705687
• Product Code: IYE
• UDI-Device Identifier: 04056481000264
• UDI-Public: 04056481000264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physicist
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 48355
• Device Catalogue Number: 20834E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other