MAUDE Adverse Event Report: Philips Medical Systems Nederland B.V. Brilliance iCT; System, X-Ray, Tomography, Computed

Model Number	Brilliance iCT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint has been evaluated based on the information provided.During servicing of the brilliance ict system, a philips field service engineer sustained an injury to the left hand while cleaning the ct slip ring when the gantry was moved while the engineer¿s hand was positioned in a known pinch-point area.The event resulted in a laceration across the left index finger at the metacarpophalangeal joint, an approximately 0.5-inch laceration on the dorsal aspect of the index finger, a puncture wound to the index finger, and a crush/pinch injury to the left little finger.The employee initially received first-aid treatment consisting of wound cleaning and bandaging and was subsequently evaluated and treated in the emergency department.Medical treatment included placement of five sutures in the index finger.X-ray examination confirmed the absence of fractures.Subsequent evaluation by a hand specialist documented ongoing numbness and tingling in the left index and little fingers; however, the presence or extent of any permanent impairment could not be determined at the time of assessment.Based on the available information, this issue has been determined to be a reportable event.Philips has started an investigation into this complaint.We will file a follow-up emdr at the completion of the investigation.
Additional Manufacturer Narrative
We have not completed our investigation of this event.Upon completion, we will submit a follow-up emdr report.Internal cross reference: complaint pr#(b)(4).

• Brand Name: Brilliance iCT
• Common Device Name: System, X-Ray, Tomography, Computed
• Manufacturer (Section D): Philips Medical Systems Nederland B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): Philips Medical Systems Nederland B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: john maga ; 3000 minuteman rd; andover, MA 01810 ; +1(617)245-5900
• MDR Report Key: 50856741
• Report Number: 3015777306-2026-100005
• Device Sequence Number: 13138618
• Product Code: JAK
• UDI-Device Identifier: 00884838059474
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: Other
• Device Model Number: Brilliance iCT
• Device Catalogue Number: 728306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 11/07/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: White