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

Model Number 4068210

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Full thickness (Third Degree) Burn (2696)

Event Date 06/09/2023

Event Type  Injury  

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 reported that a patient developed a burn during a 2-3 hour surgical procedure using the iled 7 surgical light system.The burn was noted to be a ¿full skin burn¿ with characteristics reported as ¿redness medial to the surgical incision¿ and ¿blistering¿ at an unspecified later time.The patient¿s burn was treated with ¿cooling bandages and a pca (patient-controlled analgesia) pump".Based on the report that the patient sustained a full skin burn and the patient required medical intervention (cooling bandages and an analgesic pump) to possibly preclude permanent impairment of a body structure or permanent damage to body function, concludes a serious injury occurred.This report was filed in our complaint handling system as complaint #(b)(4).

Event Description

It was reported that a patient developed a burn during a 2-3 hour surgical procedure using the iled 7 surgical light system.The burn was noted to be a full skin burn with characteristics reported as redness medial to the surgical incision and blistering at an unspecified later time.The patient¿s burn was treated with cooling bandages and a pca (patient-controlled analgesia) pump.Based on the report that the patient sustained a full skin burn and the patient required medical intervention (cooling bandages and an analgesic pump) to possibly preclude permanent impairment of a body structure or permanent damage to body function, concludes a serious injury occurred.This report was filed in our complaint handling system as complaint #c-2028156.

Manufacturer Narrative

Based on the provided information by the customer (initial user report, follow-up information, first on-site visit, video call) it was determined that several light fields with high intensity were overlapped by the user.Overlapping light fields with high intensity may cause burns in the wound area or skin.This residual risk is described within the instructions for use.An on-site investigation was conducted, and two light heads were exchanged from the customer location to perform a deeper device investigation at our facility.A second visit at the affected customer location was done in week 3 of 2024.The team consists of functions from technical service, r&d, quality assurance, medical affairs, medical device vigilance and our distributor.Interviews and discussions were held with the staff of the surgical rooms to obtain more information on the use of surgical lights, staff training and knowledge of general risks associated with surgical lights.Additionally, more iled 7 lights in several operating rooms were inspected and data gathered for further investigation.Conversations with the biomedical engineers about their findings and investigations on the lights were also done.As a result the root cause was traced to overlapping of several light fields with high intensity.The iled 7 surgical light was designed according to (b)(4) and meets these requirements.The iec also indicates that overlapping of more than one light field (luminaires) can exceed the irradiance of 1000 w/m².Therefore, information shall be given with the instructions for use (ifu) that there is a risk of too much heat in the operating field.The iled 7 ifu includes a warning for this risk as well as for other conditions where it is possible to increase the irradiance.The 1000 w/m² are the limits for potential undesirable temperature rise in the operating field per the iec.The iled 7 produces 623 w/m² for the single light head.In case of overlapping with high intensity the 1000 w/m² may be exceeded.From the overall investigation some other findings were available.Not at all light heads the calibration values were available which ensures the correct distance measuring and following the correct light setting.This may lead to higher values but this was evaluated to not contribute to skin burns as a solely cause.Additionally, in case the light head is moved very slowly and carefully, the motion sensor does not recognize a movement of the light head.Following this, the light head will not trigger a new distance measurement.This led to higher values which may contribute to skin burns.This behavior was determined to be not a use case.It was only reproduceable when moving the light head with two hands very slowly and sensitive up or down.In the normal surgical environment the light head will be moved with one hand on the center handle or with one hand at the housing.Doing this, it could not be reproduced that the sensor will not recognize a movement.Based on the root cause investigation the instructions for use (ifu) will be updated to include further advise and guidance on led overhead light handling/usage.Additionally, the remaining risk will be described in more detail.A fsca will be initiated to provide each user/customer this updated ifu as well as awareness of the potential risk.Further, it will be evaluated which technical update can be provided to customers to reduce the risk further.This evaluation is currently ongoing but will also be considered within the fsca execution.

• 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: 17771994
• MDR Text Key: 323687607
• Report Number: 3007143268-2023-00035
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• 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
• 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