MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ILED7 SURGICAL LIGHT; LAMP, SURGICAL

Model Number	4068310
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient sustained a burn with an iled7 surgical light.The patient was undergoing a three-hour thyroid surgical procedure when a 1.5x1cm pink area ¿just below the surgical area¿ was observed to have developed.The area evolved during the continued procedure, into an area described as ¿doubling in size¿ and ¿oozing.¿ the wound was later described a ¿3x2cm burn that was pink and oozing.¿ the ¿pink area¿ had an absent outer epidermal layer indicative of a second-degree/partial thickness burn.No specific medical treatment was reported; however, it was reported that the burn injury required repositioning and follow-up with a healthcare provider.The customer attributes the injury to the use of two lamps at 80% brightness not being separated, but fixed (overlapping).The lights were not focused on the patient but on the surgical field.Additional information received noted that multiple non-baxter headlights were used in conjunction with the iled lights.No further information was available at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H3: correction.H7/h9: correction.A technician was dispatched on february to inspect the lighting system and carry out the recall.Both tasks were reported back to baxter without any abnormalities.The product is functioning as specified.Based on all available data, it can be assumed that the light fields overlapped, which led to increased intensity input in the operating area.The ifu states that if light fields overlap, the intensity at the light fixtures must be reduced or the light fields must be separated to avoid potential skin irritation or wound desiccation.The field action has been implemented on the product since february, further increasing the safety of the product¿s use.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: h6, h11.The serial numbers of the products were recorded on-site and also communicated to baxter.Based on this, it can be stated that there is only one lighting system in or9 with the serial number (b)(6) reported under the other mdr number (3007143268-2026-00007).This lighting system contains two light heads with serial numbers (b)(6).The other system (sn (b)(6)), initially assumed to be present, is not located in this operating room.According to the swedish representative, it is installed in another hospital.

• Brand Name: ILED7 SURGICAL LIGHT
• Common Device Name: LAMP, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl zeiss strasse 7-9; null; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24381640
• Report Number: 3007143268-2026-00006
• Device Sequence Number: 18767924
• Product Code: FTD
• UDI-Device Identifier: 00887761968288
• UDI-Public: (01)00887761968288
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4068310
• Device Catalogue Number: 4068310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 04/23/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/21/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3007143268-05/24/24-001-
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CUDA LUXTECH HEADLIGHTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown