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

Model Number 4068210

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event 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).

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 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).

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
• Type of Device: 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
• MDR Text Key: 323894672
• Report Number: 3007143268-2023-00037
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: 887761995857
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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
• Date Manufacturer Received: 09/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention