MAUDE Adverse Event Report: ACCURAY INCORPORATED ACCURAY TOMO HD SYSTEM; TOMOTHERAPY TREATMENT SYSTEM

Model Number	H-0000-0003
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was recently received for a problem involving an unexpected treatment couch descent.The couch fell approximately 180 mm (~7 inches).There was no injury to the patient or staff.Conditions leading to the malfunction: after completing patient set up but prior to treatment, the patient table fell suddenly.The clevis bearing had separated from the vertical actuator.The vertical actuator combines the motor, rollerscrew, encoder, and brake to safely lift and lower the treatment couch.Upon inspection, the threaded connection between the clevis bearing and actuator had been stripped.The root cause is under investigation.
Event or Problem Description
A complaint was recently received for a problem involving an unexpected treatment couch descent.The couch fell approximately 180 mm (~7 inches).There was no injury to the patient or staff.

• Brand Name: ACCURAY TOMO HD SYSTEM
• Common Device Name: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale CA 94089
• MDR Report Key: 6233849
• Report Number: 3003873069-2017-00002
• Device Sequence Number: 1057113
• Product Code: IYE
• UDI-Device Identifier: M6581043090
• UDI-Public: M6581043090
• Combination Product (Y/N): N
• PMA/510(K) Number: K121934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H-0000-0003
• Device Catalogue Number: H-0000-0003
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1