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

Model Number	G16720
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
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 lamp flashed a few times in the morning.When the lamp was moved up, it fell down.There were no health consequences for the patient, or the staff reported.
Additional Manufacturer Narrative
The affected device was examined onsite by the dräger service and the retaining ring and shim washers of the system were made available for further investigation.Examination of the retaining ring found no signs of wear which typically would occur when inserting, removing or moving the spring arm.It can be assumed that the retaining ring was not installed correctly and was also not subject to any maintenance.The customer does not have a service contract with dräger.Examination of the two shim washers found wear signs of typical use.The material abrasion is due to the rotation of the spring arm.A partial wear mark on one shim washer could be related to an incorrectly installed retaining ring or a sudden external intervention (e.G.A collision).It can therefore be assumed that the retaining properties of the ring were significantly reduced by a hard collision.Based on the available information, the failure was likely caused by a mechanical impact in conjunction with a possible installation fault.The reported flashing of the light was therefore caused by the bad connection just before the fall of the system.If the mechanical connection between the spring arm and the extension arm of the central axis is no longer properly in place, the affected subsystem can fall and thus also cease to function.The installation of the retaining ring (in its groove) is described in detail in the assembly instructions.Several relevant warnings must be observed.The assembly steps when installing the spring arm must be carried out correctly, otherwise the spring arm may fall.According to the instruction for use, the operational readiness of the support arm system must be checked before each use as part of a functional and visual inspection.The equipment system to be checked is only considered ready for operation when a flawless overall condition is ensured.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that lamp flashed a few times in the morning.When the lamp was moved up, it fell down.There were no health consequences for the patient, or the staff reported.

• 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: 20449709
• Report Number: 9611500-2024-00438
• Device Sequence Number: 7110681
• Product Code: FTD
• UDI-Device Identifier: 04048675416562
• UDI-Public: (01)04048675416562(11)210120(93)G16720-20
• 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): 12/13/2024

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: G16720
• Device Catalogue Number: G16770
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown