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

Model Number 4028210

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2022

Event Type  malfunction  

Event 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).

Manufacturer Narrative

The iled 3 was inspected by a field service technician.Further investigation is ongoing.

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 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
• Type of Device: 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
• MDR Text Key: 290373310
• Report Number: 9681407-2022-00006
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995956
• UDI-Public: 887761995956
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1