MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 100-200; LIGHTS SURGICAL

Catalog Number	G16980
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	11/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was based on the assessment of available information and considered the results of random checks of the current stock material (at draeger site), the results of an evaluation of service and repair measures in terms of this type of cardanic and the review results of the effective specifications and installation instructions.Replaced parts were not returned and therefore not available for further investigation at the manufacturer¿s site.Furthermore, the supplier of the affected part was involved in the investigation.According to the service measure, the affected cardanic showed an inappropriate assembly of shims (too many) in combination with the required retaining ring; therefore, the retaining ring had got damaged and failed.As result of the investigation, a production failure at the supplier¿s site regarding the cardanic was identified to be the root cause of the event (human factor, failure to follow the instructions).There are no further or lights installed at this showing this failure pattern.Random checks of the stock material, the assessment of worldwide requests for repair cardanics (including the reason for the request) as well as the review of the effective draeger specification and the supplier¿s assembly instructions for the cardanic arm have shown that there is no systematic error.The installation instructions of the supplier of the cardanic were considered appropriate ¿ however, in order to improve the readability and to avoid misunderstanding, pictures and measurement specifications were added to show the difference between a correct and incorrect fit of the retaining ring.Furthermore, the supplier will perform an internal training of the production personnel to increase awareness of the issue.The case was re-assessed within an internal review and considered to be reportable in case of reoccurence.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 the light head of a polaris 100/200 fell during a procedure with a patient.In the course of the investigation, however, it was confirmed by the complainant that the light head became loose and had lowered but ¿ other than initially reported - did not fall.There was no injury reported neither in terms of the patient nor any other person.

• Brand Name: POLARIS 100-200
• Common Device Name: LIGHTS 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: 18197905
• Report Number: 9611500-2023-00445
• Device Sequence Number: 6247719
• Product Code: FTD
• UDI-Device Identifier: 04048675268109
• UDI-Public: (01)04048675268109(11)220708(93)G16980-32
• 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
• Report Date (Section B): 11/23/2023

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: G16980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown