MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG TRULIGHT 5000 / 3000 MOBILE; SURGICAL LIGHT

Model Number	4038120
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Customer alleged the light head fell in the equipment room.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
Several contact attempts were unsuccessful.A concrete root cause could not be determined for the alleged light head fall.Based on this, no further action is required.
Event or Problem Description
Customer alleged the light head fell in the equipment room.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: TRULIGHT 5000 / 3000 MOBILE
• Common Device Name: 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 07318 ; GM 07318
• MDR Report Key: 17403592
• Report Number: 3007143268-2023-00029
• Device Sequence Number: 12237235
• Product Code: FSY
• UDI-Device Identifier: 00887761995833
• UDI-Public: 887761995833
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: 4038120
• Was Device Available for Evaluation?: No
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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