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

Model Number	136149
Medical Device Problem Codes	Connection Problem (2900); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that the check cable bracket tube got disconnected from the mounting block.
Additional Manufacturer Narrative
Section b1 new information.Section d9 new information.Section h3 updated information.Section h6 updated coding.Section h7 new information.Section h10 additional information.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The selector spring tube assembly became detached from the mounting block of the tdu safe, with the result that the check cable was not properly guided through the selector spring tube assembly to the selector arm.An elekta service engineer has replaced the selector unit.The manufacturing process has been improved to prevent the re-occurrence of the selector spring not being glued all around and teflon coating inside selector spring shielding spring tube.There was no patient involvement as the issue was discovered during the qa daily checks.Elekta assessed the severity of risk to be low.

• Brand Name: FLEXITRON HDR
• 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: 10791012
• Report Number: 9611894-2020-00004
• Device Sequence Number: 16977799
• Product Code: JAQ
• UDI-Device Identifier: 08717213051126
• UDI-Public: 08717213051126
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 136149
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1