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

Model Number	4028210
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a iled 3 surgical light fell down as the spring arm separated from the support arm system.The falling component hit a person at the shoulder and the knee.The person is currently on sick leave.No details of the injury , results of x-ray and medical examination were not provided by the customer so far.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The iled 3 was inspected by a field service technician.Further investigation is ongoing.
Additional Manufacturer Narrative
The iled light system was inspected by a field service technician.It was identified the snap ring which holds the spring arm in place dislodged and allowed the spring arm to separate from the central axis.Significant signs of wear was visible at the spring arm - central axis connection.Within the device history the last preventive maintenance is recorded for 2018.During the required preventive maintenance the snap ring has to be inspected for correct fit and function.The preventive maintenance is required for each year at this device age.The light system involved in the event passed it's intended design life of ten years.The root cause for the event was traced to not following the instructions for use, missing regularly preventive maintenance.The light system was repaired and checked for functionality.Based on this, no further actions are required.
Event or Problem Description
It was reported that a iled 3 surgical light fell down as the spring arm separated from the support arm system.The falling component hit a person at the shoulder and the knee.The person is currently on sick leave.No details of the injury, results of x-ray and medical examination were not provided by the customer so far.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ILED 3/5
• 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: steffen ulbrich ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 14249897
• Report Number: 9681407-2022-00006
• Device Sequence Number: 19932944
• Product Code: FSY
• UDI-Device Identifier: 00887761995956
• UDI-Public: 887761995956
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 4028210
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/25/2022
• 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