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

Model Number	G4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial investigation is that no malfunction occurred, and this is a known expected side effect; however, the investigation is ongoing, and a final investigation will be provided once complete.
Event or Problem Description
A patient contacted accuray and provided the following information: had cyberknife treatment in 2014 at (b)(6) hospital.Shortly after the treatment the i had urinary incontinence followed by later fecal incontinence.Both are uncontrollable.There are surgeries to help correct this problem however i do not wish to go this route and very dissatisfied with the outcome.
Additional Manufacturer Narrative
An interview was conducted with the patient.A review of literature on known side effects of external beam radiation therapy for the treatment of prostate cancer was completed.It is unknown if the patient had any other risk factors that affected the risk of developing these toxicities.Urinary and fecal incontinence are known acute and late genitourinary and gastrointestinal toxicities associated with external beam radiation therapy to the prostate and surrounding area.A review of complaints from the site that the patient received their treatment at was completed.No non-conformity was identified.In conclusion, no system defect was identified during the time the patient received treatments.The investigation determined that the individual has expected, known side effects from radiation treatment.

• 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: 15078585
• Report Number: 3003873069-2022-00013
• Device Sequence Number: 4772976
• Product Code: IYE
• UDI-Device Identifier: M6580330000
• UDI-Public: +M6580330000/16D20180611B
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: G4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2022
• Supplement Date Received by Manufacturer: 07/02/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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: Disability
• Patient Sex: Male