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

Model Number	4047020
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inspection of the iled lights was performed by a hillrom technician using an mt-912 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-max limit of intensity.In this event, the customer reported the intensity level of the surgical lights was too high and the patient sustained an open sore on the right shoulder that required medical intervention (excision and suture) 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 the lights 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 or Problem Description
The customer reported that during use of the iled7 surgical lights, the intensity level of the lights was too high and while closing the surgical incision, the fellow noted an open sore on the patient¿s right shoulder.The wound was excised, closed with suture and dressings applied.During a follow-up visit with the patient, the wound was found to be healing without issue.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ILED 7
• 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: 17115999
• Report Number: 3007143268-2023-00021
• Device Sequence Number: 6593726
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: 887761995857
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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: 4047020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/13/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male