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

Model Number	4028110
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device involved in this event passed it's expected lifetime of 10 years.An offer will be made to the customer to replace the damaged lights.The surface coating process has been updated to include additional testing and verification.Based on this information, no further action is required.
Event or Problem Description
The customer alleged that paint is falling down from the surgical light.No injury or impact to any surgical procedure was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ILED CEILING DUO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 12565705
• Report Number: 9681407-2021-00032
• Device Sequence Number: 17157189
• Product Code: FSY
• UDI-Device Identifier: 00887761995963
• UDI-Public: 887761995963
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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
• Operator of Device: No Information
• Device Model Number: 4028110
• 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: 09/20/2021
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1