MAUDE Adverse Event Report: ELEKTA LTD VERSA HD; ACCELERATOR, LINEAR, MEDICAL

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported a radiation exposure incident.
Additional Manufacturer Narrative
Elekta ref.(b)(4) was previously submitted under mfr report no.9612186-2023-00007 (elekta instrument ab) on 31st august 2023, due to an administrative error this should have been submitted under mfr ref no.9617016-2023-00001 (elekta ltd).The investigation was completed by conducting a thorough evaluation of the product and the reported information.The investigation found that during service activities, two radiotherapists entered the treatment room.An elekta field service engineer was completing service activities and started delivering a beam without realising that one of the radiotherapists was still present in the treatment room.The radiotherapist was performing positioning activities to the linac which would indicate they were not standing in immediate vicinity of the gantry.Once the radiotherapist heard the audible noise from the linac indicating that a beam had been started they ran towards the treatment room maze to disable the beam via the emergency stop button but they saw the open door button and pressed that instead.The field service engineer turned off the beam via the console once they heard someone shouting from the treatment room.The beam was on for approximately three seconds.The hospital's radiation safety officer (rso) advised that the radiotherapist's radiation detection badge that they were wearing at the time of the event be sent to the vendor for an immediate reading.Elekta have concluded that no new risks have been identified and that this incident was due to use error.Facilities should have protocols in place when a linac is being serviced not to enter the treatment room.Actual injury was sustained to a radiation therapist but the amount of unintended radiation exposure is unknown to elekta, although the rso determined that the exposure level was very minimal.

• Brand Name: VERSA HD
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer (Section G): ELEKTA LIMITED; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 18011715
• Report Number: 9617016-2023-00001
• Device Sequence Number: 18009729
• Product Code: IYE
• UDI-Device Identifier: 05060191071017
• UDI-Public: 05060191071017
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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: 06/20/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2017
• 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