MAUDE Adverse Event Report: NUCLETRON B.V. FLEXITRON HDR; SYSTEM,PLANNING,RADIATION THERAPY TREATMENT

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation found that after measuring the non-elekta plastic needles which are trimmed in the operating room (or), a wrong indexer length (off by 2cm) was applied in the treatment plan by the users, with which the patient was treated.Replanning was performed to compensate for the underdose, and at the same time considering the delivered dose to organs at risk (e.G.Urethra).With that, the underdose was to a large extend compensated and based upon the information available elekta has assessed the severity of the overdose related to the incident as serious.The root cause of the issue was determined to be use error.The hospital uses non-elekta plastic needles which are being trimmed in the or to a certain length and thus requires length measurements per needle for exact length indication to be used in oncentra brachy.This introduces a more complex workflow compared to using elekta proguide needles with defined lengths.The instructions for use for the source position simulator clearly describes how to read the indexer length and internal length.The oncentra brachy user manual contains a 'treatment plan approval checklist' in which the user is requested to verify the indexer length in the treatment plan.Using non-elekta needles is a contributing factor for the use error.Flexitron/source position simulator and oncentra brachy did not malfunction and worked as designed and intended.
Event or Problem Description
It was reported that the user misread flexitron sps.
Additional Manufacturer Narrative
Unfortunately due to administrative errors, the following fields have now been updated.B1 - adverse event ticked.B2 - other serious or important medical events ticked.B3 - date of event added.G2 - report source - foreign removed.H1 - serious injury - selected.H2 - updated as correction.

• Brand Name: FLEXITRON HDR
• Common Device Name: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section D): NUCLETRON B.V.; waardgelder 1; veenendaal 3905 TH; NL 3905 TH
• Manufacturer (Section G): NUCLETRON B.V.; waardgelder 1; veenendaal, 3905 TH; NL 3905 TH
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 20321937
• Report Number: 9611894-2024-00001
• Device Sequence Number: 20878875
• Product Code: JAQ
• UDI-Device Identifier: 08717213051126
• UDI-Public: (01)08717213051126
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K070574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown