MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7; SURGICAL LIGHT

Model Number 4068310

Device Problem Use of Device Problem (1670)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Upon device inspection no malfunction of the operating light system was identified and the event could not be duplicated.It is known and clearly indicated within the instructions for use that overlapping of two or more light fields may lead to tissue damage and cannot be ruled out as not occurring for this event.Initial inspection noted the product to be functioning as designed, however, additional investigation is pending.Therefore, (b)(6) is cautiously reporting this event due to the serious injury involved.If additional information will become available a follow-up report will be submitted.

Event Description

The customer alleged post-surgery the surgical team noted an oblong red wound on the medial side of the patient¿s left breast, which was initially thought to be due to the adhesive.When the patient returned to the clinic for her post-op visit a plastic surgery consult was performed.The wound was diagnosed as a third-degree burn, silvadene cream was applied, and they plan to monitor the patient for next steps.The customer states a wound graft is possible for future treatment.It is believed by the customer the operating light system iled 7 which was used during the surgical procedure caused or contributed to the injury.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): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 12516031
• MDR Text Key: 272852157
• Report Number: 9681407-2021-00026
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2021

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 Operator: No Information
• Device Model Number: 4068310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/22/2021
• 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