MAUDE Adverse Event Report: NUCLETRON B.V. ONCENTRA BRACHY; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number	170730
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Oncentra brachy offers applicator modelling functionality, which aids the end-user in the reconstruction of an entire applicator geometry by using anchor points.During the root cause analyze of a reported customer complaint, unique scenario's have been identified that could potentially lead to the applicator to be mirrored.The error condition was first detected by the (b)(4) engineering team on (b)(6) 2021.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.1.In the unique scenario, where applicator modelling is used for the venezia¿ applicator (called advanced gynecological applicator in the applicator library manager) in combination with using both the o1 center and o2 center anchor points as part of the used set of anchor points.2.In the exceptional scenario, where during placement of the applicator anchor points the user accidentally swaps two symmetrically located anchor points of the model, the applicator could get placed with the left and right channels mirrored.This situation could apply to all applicator models that are symmetrical in the left-right direction.This is caused by a design fault in the mapping of the applicator model to the user provided anchor points.Based on the available information there has been no actual mistreatment.An important field safety notice will be sent to all affected customers from 15 october 2021 ((b)(4) reference #fca-nu-0007).A software update will be released addressing the defect which is estimated march 2022.

• Brand Name: ONCENTRA BRACHY
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B.V.; waardgelder 1; veenendaal 3905 TH; NL 3905 TH
• MDR Report Key: 12561892
• Report Number: 9611894-2021-00001
• Device Sequence Number: 13809965
• Product Code: MUJ
• UDI-Device Identifier: 08717213052758
• UDI-Public: 08717213052758
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 170730
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1