MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 1000 / CEILING; SURGICAL LIGHT

Model Number	4058110
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A trumpf medical service technician was dispatched to evaluate the light system, however, a technician has been unable to access the device for further investigation and possible device return.No further information is available at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
The customer alleged, the light head dislodged from the spring arm and was hanging on the cables.No injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The examination light was evaluated by a hillrom technician.It was identified a metal plate was broken which caused the light head to detach.Upon further engineering investigation it was concluded, the metal plate broke due to an overload (e.G.Collision, mishandling).A material of design defect was not identified.The device was repaired by a hillrom technician and is functioning as designed.Based on the investigation results no further actions are necessary.
Event or Problem Description
The customer alleged, the light head dislodged from the spring arm and was hanging on the cables.No injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TRULIGHT 1000 / CEILING
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 10256960
• Report Number: 9681407-2020-00043
• Device Sequence Number: 2603767
• Product Code: FSY
• UDI-Device Identifier: 00887761986084
• UDI-Public: 887761986084
• 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): 02/08/2021

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: 4058110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2020
• Supplement Date Received by Manufacturer: 06/21/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1