MAUDE Adverse Event Report: REFLEXION MEDICAL, INC. REFLEXION X1; REFLEXION MEDICAL RADIOTHERAPY SYSTEM

Model Number	RXM1000
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	10/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reflexion has investigated the issue and determined the cause to be a code implementation defect in the treatment planning software.When reflexion's treatment planning system calculates dose, an accurate orientation for image, dose, primary beam, and scatter orientation (dose angles) is necessary.The scatter orientation in the dose calculation algorithm is incorrect for any patient orientation other than head first supine (hfs).The other patient orientations are head first prone (hfp), feet first prone (ffp), and feet first supine (ffs).Treatment plans for hfs are not affected.
Event or Problem Description
Patient (b)(6) received 22 out of 25 planned fractions for prostate bed + lymph node on the reflexion x1 system, and 3 additional fractions on another system.During the course of his treatment, the patient received an overdose to the ptv of 7.8%, exceeding clinical treatment goals.There were associated overdoses to organs at risk (oars).The additional dose to these organs may raise the risk of short-term or long-term injury beyond known baseline risks of prostate bed radiotherapy.

• Brand Name: REFLEXION X1
• Common Device Name: REFLEXION MEDICAL RADIOTHERAPY SYSTEM
• Manufacturer (Section D): REFLEXION MEDICAL, INC.; 25881 industrial blvd; hayward CA 94545
• Manufacturer (Section G): REFLEXION MEDICAL INC.; 25881 industrial blvd; hayward CA 94545
• Manufacturer Contact: aarti shukla ; 25881 industrial blvd; hayward, CA 94545 ; 2138415999
• MDR Report Key: 13006612
• Report Number: 3011716550-2021-00001
• Device Sequence Number: 5441198
• Product Code: MUJ
• UDI-Device Identifier: 00860003983805
• UDI-Public: (01)00860003983805(11)210524
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: RXM1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3011716550-12/9/21-001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose