MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG ILED 7 CEILING DUO; SURGICAL LIGHT

Model Number	4068210
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient received burns during a surgical procedure using the iled 7 surgical light system.Specific details of the alleged burn were not reported.Multiple attempts to obtain additional details of the event, classification of the burn, characteristics of the burn, and medical treatment provided were unsuccessful.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
Inspection of the device is pending.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
Event or Problem Description
It was initially reported that a patient sustained a burn during a surgical procedure using the iled 7 surgical light system.Additional details received described the burn as blisters to the left groin lateral to the surgical incision.¿ the area was noted to have been treated with an ¿absorbent dressing to keep the wound moist.¿ no additional intervention was reported.Per the image provided, the injury is noted to measure 6 cm² at 15-46 days post-operative.The image shows two raised open red areas with slight white blotchiness and slight charred edges, with the appearance of partial-thickness second to third-degree burn.Based on the image provided by the customer, the injury appears to be a serious injury and would typically require medical intervention to preclude permanent impairment.This report was filed in our complaint handling system as (b)(4).
Additional Manufacturer Narrative
The causality of the burn is unable to be determined at this time as the investigation is ongoing, additionally, an inspection of the device performed by a baxter representative is pending, therefore the functionality of the device cannot be determined at this time.If any additional relevant details are received the complaint will be addressed accordingly.

• Brand Name: ILED 7 CEILING DUO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 17787254
• Report Number: 3007143268-2023-00037
• Device Sequence Number: 15316887
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: 887761995857
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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?: Yes
• Device Model Number: 4068210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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: Required Intervention
• Patient Sex: Unknown