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

Model Number M6

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

It was reported that the synchrony boom arm was loose.

• Brand Name: CYBERKNIFE
• Type of Device: MEDICAL LINEAR ACCELERATOR
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 12974112
• MDR Text Key: 282041620
• Report Number: 3003873069-2021-00006
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K170788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/10/2021

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
• Device Operator: Health Professional
• Device Model Number: M6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• 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