MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INC. CLINAC-IX; LINEAR ACCELERATOR

Model Number	H293318
Medical Device Problem Codes	Inadequate User Interface (2958); Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiation therapist was standing at the end of the table.Therapist's right hand palm was under the couch, and therapist floated/released the couch top towards the gantry.The therapist's pinky fingertip on right hand, got caught between couch top and table base.This resulted in 3-4mm of the therapist's fingertip/skin was cut.Stitches needed to address injury.
Event or Problem Description
Radiation therapist was standing at the end of the table.Therapist's right hand palm was under the couch, and therapist floated/released the couch top towards the gantry.The therapist pinky finger tip on right hand, got caught between couch top and table base.This resulted in 3-4mm of the therapist finger tip/skin was cut.Stitches needed to address injury.
Event or Problem Description
See completed mw-2023-00007 mfr 2916710.
Additional Manufacturer Narrative
The reported issue is that the user was expecting to move the couch top.However, the user needed to be careful to observe and maintain clearance to the couch surface and couch tabletop as to not suffer any pinch point injury.A pinch point label is posted on the couch top warning of this danger.The user had her right hand extended and the pinky got caught between the couch top and couch final assembly.This was user error.The investigation confirmed the issue did occur.The issue was caused by inadequate float handle gripping distance and/or excessive gap between the exact couch final assembly tm53391 and tm533392 exact couch tabletop.Varian has labeled the pinch hazards with decals on the top of the couch and has noted the hazards in the instructions for use manual.Warnings are found for pinch point, via decals on the couch surfaces to avoid injury when in close proximity to pinch points.The instructions for use for the exact couch manual (varian document 1104201-05 published in august 2011) in chapter 2, page 26-27 defining cautions to avoid as couch pinch points as clearly labeled on the couch as per ctb ps-767 dated on 8 sept 2010.Chapter c of the appendix pages 108-111 list descriptions of the couch pinch points.The therapist and customer should proceed with caution when in proximity of this couch pinch point and to the warning label as posted.

• Brand Name: CLINAC-IX
• Common Device Name: LINEAR ACCELERATOR
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS INC.; 911 hansen way; palo alto CA 94304
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 17822361
• Report Number: 2916710-2023-00006
• Device Sequence Number: 2302259
• Product Code: IYE
• UDI-Device Identifier: 00899475002042
• UDI-Public: 00899475002042
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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: H293318
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2006
• 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: Other
• Patient Sex: Unknown