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

Model Number	4028210
Medical Device Problem Codes	Structural Problem (2506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was inspected by a field service technician.It was identified the snap ring, which secures the spring arm at the central axis became loose allowing the spring arm to separate from the central axis.The spring arm was reinstalled using a new snap ring to resolve the issue.The investigation of the reported failure is ongoing.Additional information identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
The customer reported the spring arm with light head separated from the central axis.It did not fall down.No injury or impact to a surgical procedure reported.This report was filed in our complaint handling system as complaint #(b)(4).
Event or Problem Description
The customer reported the spring arm with light head separated from the central axis.It did not fall down.No injury or impact to a surgical procedure reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The spring arm which detached was installed by trumpf medical on (b)(6) 2021 as a spare part.The device was inspected by a trumpf medical field service technician.It was determined that the snap ring, which secures the spring arm at the central axis, became loose as a result of an installation failure on (b)(6) 2021, which allowed the spring arm to separate from the central axis.The engineering investigation indicated if the snap ring is not installed correctly or is not properly seated in the groove it can become loose.Then, over time and through normal use, the spring arm can slowly descend from its original position and the spring arm can separate from the central axis.Other effects of improper snap ring installation include difficulty moving the spring arm, a noticeable gap between the spring arm and central axis, and the potential for a loss of light.These effects would be evident prior to the spring arm becoming dislodged from the central axis.The root cause was traced to an installation failure of the snap ring.Several evaluations by ondal medical systems and trumpf medical concluded that if the snap ring is installed properly, the snap ring will not come out of the groove during the lifetime of the device.Based on this, no further actions are necessary.

• Brand Name: ILED 5/3 DUO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; 7-9 carl-zeiss-strasse; saalfeld 07318 ; GM 07318
• MDR Report Key: 11471803
• Report Number: 9681407-2021-00013
• Device Sequence Number: 11583388
• Product Code: FSY
• UDI-Device Identifier: 00887761995956
• UDI-Public: 887761995956
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 4028210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1