MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB ELEKTA SYNERGY; ACCELERATOR, LINEAR, MEDICAL

Medical Device Problem Codes	Insufficient Cooling (1130); Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Device Sensing Problem (2917)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported bending magnet failure.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The hospital reported that while using the linac, the mlc was no longer recognized.When the hospital staff entered the treatment room, there was a strange smell.The issue happened during inspection and there was no patient on the table.After noticing the strange smell, the hospital contacted elekta's care support centre and a field safety engineer arrived on site.There was burnout around the bending magnet and flight tube.It was found that there was water leakage from the cooling piping of the bending magnet.The field safety engineer replaced the bending magnet and flight tube parts.The linac has a bending ot interlock to give an inhibit to the machine to radiate.If the coil is overheating, water temperature or the water pressure interlocks if there is not enough water or it is too hot to the cooling system.The customer raised the case few months later after the incident happened therefore the sdd logs are not available to check if the inhibit was displayed on the monitor.In case of fire, it is stated in the 'site planning environmental information' manual that a co2 fire extinguisher should be present in the treatment room, control area and water cooler area to deal with electrical fires.It is also states that the hospital should install smoke detectors in the treatment room.The hospital was following this as there were fire extinguishers and smoke alarms present.The root cause for this issue has not been identified as the sdd logs were not available.It is likely possible to be a burnout as there was not enough cooling in the bending coil but this should have been detected by the interlock.The issue of burnout is a known risk (severity "non-serious" and probability "incredible") and the risk assessment concluded that the risk is low.
Additional Manufacturer Narrative
Section d4 corrected.The udi for this product should have been udi (b)(4) with serial number (b)(6).Section g4: 510 k number corrected.Section h4: manufacturer date added.This is a follow-up to the final report submitted on 17 april 2024 to notify that the product information has been updated.

• Brand Name: ELEKTA SYNERGY
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgaten 18; po box 7593; stockholm, 103 9 3; SW 103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; kungstensgaten 18; stockholm, 103 9 3; SW 103 93
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 18484902
• Report Number: 3015232217-2024-00004
• Device Sequence Number: 9016783
• Product Code: IYE
• UDI-Device Identifier: 05060191071505
• UDI-Public: 05060191071505
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2024

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?: No
• Operator of Device: Health Professional
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 12/11/2023; Not provided
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 04/17/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2012
• 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