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

Model Number	4068310
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an iled 7 ceiling trio burned a patient.The patient was undergoing a right partial knee replacement in the operating room.The procedure lasted one and a half hours in which three iled lights were utilized.The patient had a history of ¿sensitive skin¿.When the surgical drape (ioban) was removed, the patient¿s skin was removed along with the adhesive ioban drape.The patient reportedly had a ¿teacup size and shape burn at the top of the surgical incision site.¿ the customer described the burn as ¿a full thickness burn with tissue necrosis.¿ the patient was provided with an unknown ointment and in home wound care.The customer reported that the treatment for the patient¿s burn is ongoing, and that the patient met with a plastic surgeon and ¿will likely need surgery for wound debridement¿ in the future.Warnings include overlapping fields of illumination of several lamp heads with high lighting intensities can cause tissue damage.The ifu states ¿overlapping field of illumination of several lamp heads with high lighting intensities can cause tissue damage.With early onset of tissue dehydration, separate the overlapping fields of illumination of multiple lamp heads and reduce the lighting intensity of the lamp heads.¿ additionally, the ifu states according to the laws of physics, visible light also produces heat in the operating area.If the fields of illumination of more than one lamp head overlap, high illumination levels are created, which may lead to tissue dehydration especially with longer periods of exposure and reduced blood circulation, to tissue damage.In case of reduced blood circulation or any symptoms of tissue dehydration, the lighting intensity must be reduced.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h3, h6, h7, h9 an h11.H11: upon discussion with the customer, the customer stated they did not receive the recall letter.Additionally, the customer confirmed the light heads were being used simultaneously, the autofocus was not used, and the lights were set to high intensity.A qualified baxter technician was sent to the site and inspected the lighting system and found the lights to be performing according to product specifications.All fa-2024-035 information is now available at the customer site.On july 1, 2025, it was confirmed that the default setting for light intensity when switching on the lights is now 50%.On july 30, 2025, the upgrade was installed on the ipad.In summary, due to the overlap of light fields with high intensity settings without the use of autofocus, the illumination intensity in the surgical area was increased.This can occur with 3 lights, but also with 2 lights with high intensity settings.The customer has been educated on the correct use of the device.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ILED7 SURGICAL LIGHT
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl zeiss straã¿å¸e 7-9.; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22554219
• Report Number: 3007143268-2025-00054
• Device Sequence Number: 21257699
• Product Code: FSY
• UDI-Device Identifier: 00887761968288
• UDI-Public: (01)00887761968288
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown