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

Model Number RXM1000

Device Problem Application Program Problem: Dose Calculation Error (1189)

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

Event Date 11/17/2021

Event Type  malfunction  

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 Description

Patient (b)(6) received 15 out of 25 planned fractions for prostate bed + lymph node on the reflexion x1 system.During the initial 15 fractions on x1, the patient received an overdose of 9.6% to the planning target volume (ptv) due to a defect in the treatment planning software dose calculation.After the issue was identified, he received the rest of his treatment on another radiotherapy device, with the treating radiation oncologist deciding to drop some of the remaining fractions to compensate.The actual final delivered prescription dose amounted to a 1.25% underdose, which still meets clinical treatment goals.The final, aggregate delivered dose to all organs at risk still fell within acceptable tolerance dose limits.There is no expectation that the final dose distribution would cause excess risk of harm beyond the baseline level of risk of prostate bed radiotherapy.Additionally, the increase in the risk of secondary malignancy is minimal in this scenario.

• Brand Name: REFLEXION X1
• Type of Device: 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: 13011492
• MDR Text Key: 288052227
• Report Number: 3011716550-2021-00002
• Device Sequence Number: 1
• Product Code: MUJ
• UDI-Device Identifier: 00860003983805
• UDI-Public: (01)00860003983805(11)210524
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RXM1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3011716550-12/9/21-001-C
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose