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 Unintended Radiation Exposure (4565)

Event Date 10/31/2021

Event Type  Injury  

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 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
• 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: 13006612
• MDR Text Key: 282269903
• Report Number: 3011716550-2021-00001
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• 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: 11/15/2021
• 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 Outcome(s): Other
• Patient Sex: Prefer Not To Disclose