MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 5 / ILED 3; OPERATING LIGHT SYSTEM

Model Number 4028210

Device Problems Degraded (1153); Flaked (1246); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to evaluate the light system.Due to several damages it was advised to exchange the light head and support arm system.The investigation identified steps in the preparation for coating process, which can lead to lack of paint adhesion resulting in paint chipping.Additionally, collisions of the light heads and use of unapproved cleaners can further contribute to paint chipping from the light system.The damage to the painted surfaces usually does not develop suddenly but develops over time.The instructions for use state that the devices must be checked for proper condition prior to each use.Damaged devices must not be used.If damage to the surface coating is recognized and removed, there is no danger to the patient.The surface coating process has been updated to include additional testing, and verification.No records for a regular maintenance as required per the ifu are existing.Based on this information, no further action is required.

Event Description

The customer alleged a defect led module.During device evaluation it was noticed that also paint is chipping from the light head, and support arm.No injuries were reported in relation to these allegations.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ILED 5 / ILED 3
• Type of Device: OPERATING LIGHT SYSTEM
• 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: 10725754
• MDR Text Key: 212715063
• Report Number: 9681407-2020-00060
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4028210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/23/2020
• 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