MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 600; LIGHT, SURGICAL

Model Number	G16772
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the display arm was falling apart and hanging by its wires.No patient or staff injury reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the display arm was falling apart and hanging by its wires.No patient or staff injury reported.
Additional Manufacturer Narrative
The affected device was examined onsite by the dräger service and the collected information including photos were provided for further investigation.The affected light system was installed in january 2023 and has been in use for about 18 months.The affected spring arm did not fall down and was held in place by the frictions brakes as expected.The provided photos showed a visible gap where no washers (shims) were installed under the retaining ring (circlip) of the spring arm.The washer prevents unspecified movements of the retaining ring, and the assembly instruction states: ¿possible twisting of the retaining ring can cause the spring arm to come loose during rotational movements.The shim must be present under the circlip.¿ the device was repaired by replacing the retaining ring and installing it according to the assembly instruction.The spring arm is attached to the cantilever arm of the central axis with a retaining ring (circlip).If this ring is not inserted correctly during assembly, is bent too much during insertion or is assembled without the washers, it can be levered out of the intended pin groove.As a result, the mechanical connection between the cantilever arm and the spring arm is lost and the spring arm system can move and possibly fall down.The condition of the system is checked during commissioning, maintenance and in case of a repair.Dräger was not involved in the installation at the customer site.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: POLARIS 600
• Common Device Name: LIGHT, SURGICAL
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20949852
• Report Number: 9611500-2024-00572
• Device Sequence Number: 8244538
• Product Code: FTD
• UDI-Device Identifier: 04048675416562
• UDI-Public: (01)04048675416562(11)221104(93)G16720-23
• Combination Product (Y/N): N
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: Health Professional
• Device Model Number: G16772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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