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

Model Number M6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Neuropathy (1983)

Event Date 10/22/2022

Event Type  Injury  

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 Description

Side effect - anesthesia delarosa (ad).

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
• Type of Device: 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
• MDR Text Key: 303542814
• Report Number: 3003873069-2022-00018
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00811376030016
• UDI-Public: 010081137603001611200107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female