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

Device Problems Break (1069); Crack (1135); Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

The customer reported mechanical damage to the middle arm housing, metal crack at gantry at 160 degrees.

Manufacturer Narrative

Section d5 additional information section h6 coding added section h7 additional information section h10/h11 additional information the investigation was completed by conducting a thorough evaluation of the product and the reported information.The linac was taken out of service as a precautionary measure.The complete xvi sub system was replaced with a new unit and the unit with the suspected fault was sent to a third-party supplier for investigation.The investigation did not reveal any cracks in the cast aluminium parts and appeared that only the paint coating was cracked.The cracks in the casting are merely superficial cracks in the coating paint.The cover over the solenoid assembly is not a structural part.It is not known why it appeared to be cracked around the solenoid aperture of the iviewgt, but this would not cause injury to patients and clinical users.The customer received a new replacement.There were no injuries to clinical users and patients reported.

• Brand Name: ELEKTA SYNERGY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 11848400
• MDR Text Key: 260726754
• Report Number: 9617016-2021-00004
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K192242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1