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

Model Number 4047020

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2023

Event Type  Injury  

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 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
• 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: 17115999
• MDR Text Key: 317031708
• Report Number: 3007143268-2023-00021
• 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: 4047020
• 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: 61 YR
• Patient Sex: Male