MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TRULIGHT 5000 / 3000 CEILING DUO; SURGICAL LIGHT

Model Number	4038210
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Baxter received a report stating that trulight 5510 cap detached from the spring arm.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
The device is intended to be used to provide visible illumination of the surgical field or the patient.The examination light was evaluated by a baxter technician.Upon inspection, it was found that the flat head screw that secures the sleeve was missing.This allowed the sleeve to be pushed upwards, exposing the retaining segment and causing it to slide out of the groove.This caused the lamp head to no longer be securely held and falling down.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this device after delivery in 2013.The cause of the missing screw is unknown.Due to the device age (12 years), the product requires annual maintenance according to the ifu.Checking the retaining segment is part of the maintenance procedure and must be performed by a qualified service technician.The maintenance and repair of retaining segment is described in the service manual #(b)(4).This involves loosening the screw and pushing the retaining sleeve upwards to check the retaining segment for wear.The screw may have been forgotten or incorrectly installed during this procedure, or it may not have been detected if it was already missing.The device was replaced.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of a light cap detached from spring arm were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that trulight 5510 cap detached from the spring arm.No harm or significant impact to the surgical procedure was reported.

• Brand Name: TRULIGHT 5000 / 3000 CEILING DUO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl zeiss strasse 7-9; saalfeld, thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22841607
• Report Number: 3007143268-2025-00065
• Device Sequence Number: 4848973
• Product Code: FSY
• UDI-Device Identifier: 00887761968400
• UDI-Public: (01)00887761968400(11)130627
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 4038210
• Device Catalogue Number: 4038210
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2013
• 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
• Patient Sex: Unknown