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

Catalog Number	G16772
Medical Device Problem Codes	Positioning Failure (1158); Structural Problem (2506); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008); Device Fell (4014)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Event or Problem Description
It was reported the light head was loose.There was no patient involvement.There was no indication of the light hanging/dangling.In case of recurrence a fall of the system and a risk from parts falling down cannot be completely excluded.
Additional Manufacturer Narrative
The investigation of the affected polaris 600 was based on the reported event, correspondence, and provides photos and video.Furthermore, a dräger service technician examined the device onsite.The affected retaining ring was physically not available.Thus, the investigation was limited to an assessment of provided photos, a video and information.According to the investigation results, the root cause of the fault can be traced back to a third-party company.It can be assumed that the retaining ring was not installed correctly.If the spring arm or the light system with its retaining ring is correctly and completely installed, all load limitations (spring arm) are observed and the system is handled properly according to the associated ifu and handover protocols, the loosening of the retaining ring and the dropping of the spring arm can be assessed as improbable.A product or design fault can be excluded.The affected retaining ring was incorrectly installed by a third-party company.The third-party company was originally trained by dräger us.Apart from the present installation fault, the third-party company has followed the relevant installation guidelines.The the third-party company was informed of the correct orientation of the retaining ring.The affected polaris 600 was restored to normal status by a dräger service technician on site.All ops with polaris 600 lights were checked for correct function at the customer's premises.There was no patient involvement reported.There was no indication of the light hanging/dangling.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 the light head was loose.There was no patient involvement.There was no indication of the light hanging/dangling.In case of recurrence a fall of the system and a risk from parts falling down cannot be completely excluded.

• 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: 18146278
• Report Number: 9611500-2023-00413
• Device Sequence Number: 7502923
• Product Code: FTD
• UDI-Device Identifier: 04048675416562
• UDI-Public: (01)04048675416562(11)230505(93)G16720-26
• Combination Product (Y/N): N
• PMA/510(K) Number: K123776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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 Catalogue 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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