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

Model Number	4028310
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged by the customer that at the start of the day it was noticed the iled lighting system at the ceiling was tilted and no longer stable.No harm or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
A first inspection identified the ceiling tube, which is mounted at the ceiling and sustains the light system, is damaged.The light system was taken out of use and dismounted from the ceiling.Further investigation is ongoing.
Additional Manufacturer Narrative
The investigation identified a welding seams at the ceiling tube was not manufactured according to the specifications.The welding seam failed which caused the light system to tilt at the ceiling.The ceiling tube was exchanged and the light system is now working as intended.The medical device involved in the event passed it¿s exceeded lifetime of 10 years.Based on this, no further action is necessary.
Event or Problem Description
It was alleged by the customer that at the start of the day it was noticed the iled lighting system at the ceiling was tilted and no longer stable.No harm or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ILED CEILING TRIO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME 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: 14852772
• Report Number: 9681407-2022-00012
• Device Sequence Number: 11350523
• Product Code: FSY
• UDI-Device Identifier: 00887761995949
• UDI-Public: 887761995949
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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 Model Number: 4028310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown