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

Model Number 4068210

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

The inspection of the iled 7 lights was performed by a hillrom/baxter technician using a light meter to measure light intensity and temperature.The inspection confirmed that all lights were functioning as designed and noted that all were within the 160,000 lux limit of intensity.In this event, the customer alleged the intensity level of the surgical lights was too high and the patient sustained a laceration that required medical intervention (suture and dermabond) to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury occurred in this case.The inspection ruled out a device malfunction; however, the customer acknowledged overlapping of light fields which likely caused or contributed to this reported event.Prevention of this type of event is outlined as described in the ifu.Based on this no further action is required.

Event Description

The customer reported that at the end of the procedure when drapes were taken down it was noted that the patient had an approximately 1" laceration on the right anterior lower leg.The laceration was cleaned, sutured and dermabond was applied.The laceration was covered with tegaderm, and the patient was taken to recovery.The patient¿s laceration healed.The customer alleged the intensity level of the surgical lights was too high and causing the injury.This report was filed in our complaint handling system as complaint # (b)(4).

• 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: 17115768
• MDR Text Key: 317038733
• Report Number: 3007143268-2023-00020
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: 887761995857
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2023

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?: No
• Device Model Number: 4068210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 73 YR
• Patient Sex: Female