MAUDE Adverse Event Report: ACCURAY INCORPORATED CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM; MEDICAL LINEAR ACCELERATOR

Model Number	M6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Neuropathy (1983)
Date of Event	10/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient contacted accuray about side effects from treatment on cyberknife system.The patient reports that she was diagnosed with anesthesia delarosa (ad) after cyberknife treatment for trigeminal neuralgia (tn).The description of her symptoms is consistent with ad, which is a rare complication associated with injury to the trigeminal nerve from surgical interventions such as cyberknife srs.There is no known effective treatment for ad.No malfunction has been confirmed.Investigation is in progress.
Event or Problem Description
Side effect - anesthesia delarosa (ad).
Additional Manufacturer Narrative
A patient contacted accuray about side effects from treatment on cyberknife system.The patient reports that she was diagnosed with anesthesia delarosa (ad) after cyberknife treatment for trigeminal neuralgia (tn).The description of her symptoms is consistent with ad, which is a rare complication associated with injury to the trigeminal nerve from surgical interventions such as cyberknife srs.There is no known effective treatment for ad.No malfunction has been confirmed.The investigation concluded there was no malfunction of the medical device.Anesthesia dolorosa is a known but rare complication after srs for trigeminal neuralgia.The patient was encouraged to contact their neurosurgeon, neurologist, or other health care provider with experience in management of trigeminal neuralgia and their current symptoms.The patient was also provided links to facial pain patient advocacy groups.No further actions are required.

• Brand Name: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
• Common Device Name: MEDICAL LINEAR ACCELERATOR
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer (Section G): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1209 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 15773666
• Report Number: 3003873069-2022-00018
• Device Sequence Number: 19611327
• Product Code: IYE
• UDI-Device Identifier: 00811376030016
• UDI-Public: 010081137603001611200107
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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
• Device Model Number: M6
• 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: 10/22/2022
• Supplement Date Received by Manufacturer: 10/22/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female