MAUDE Adverse Event Report: NUCLETRON B.V. MICROSELECTRON DIGITAL; System, applicator, radionuclide, remote-controlled

Model Number	106990
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that the treatment suddenly stopped.The treatment given to the patient was a gyn treatment for cervical cancer (3 channels).After 356.1 sec an error message appeared, and the treatment was interrupted.After this reboot, the system went into recovery mode and should have resumed treatment starting from the remaining dwell position in the channel before the error occurred.However, after the tcs reboot, the treatment was resumed from the initial dwell position in the first channel.Due to the recovery error an additional dose of 1.88gy was given to the patient.The planned dose was 2 x 8.3 gy = 16.6 gy.This occurred on the last fraction, and it was not possible to compensate for the additional dose in a subsequent fraction.The issue is due to a combination of a software issue and a use error.Treatment data recovery was incorrect due to a time difference between the treatment console and the treatment unit.The recovered treatment data and the pre-treatment report must be checked by the user before resuming treatment as instructed in the user manual.
Event or Problem Description
The customer reported that the treatment suddenly stopped.

• Brand Name: MICROSELECTRON DIGITAL
• Common Device Name: System, applicator, radionuclide, remote-controlled
• 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: 24091789
• Report Number: 9611894-2026-00001
• Device Sequence Number: 21449748
• Product Code: JAQ
• UDI-Device Identifier: 08717213020467
• UDI-Public: 08717213020467
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: 106990
• 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: 06/12/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown