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

Catalog Number	G16980
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user found a gap between the joint during the surgical change period and indicated that it may fall off.No health consequences were reported.
Additional Manufacturer Narrative
The investigation was just started; results will be provided in a follow-up report.H3 other text : on-going.
Additional Manufacturer Narrative
The affected parts were examined onsite by dräger service and related information including a picture of the faulty component were made available.Affected parts were not returned and therefore not available for further investigation at the manufacturer¿s site.The investigation was based on the assessment of all related information as provided.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 error, failure to follow the instructions).The retaining ring was either not fitted correctly in the groove or was fitted only on one side.In the current event, the affected system has been repaired.Furthermore, all polaris 100/200 systems installed at the customer¿s site were checked without deviation; no further faulty cardanic were found showing the reported fault pattern.Checks of the total stock material and the assessment of worldwide requests for repair cardanics (including the reason for the request) have shown that there is no systematic error.The installation instructions of the supplier of the cardanic were considered appropriate ¿ however, 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.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.H3 other text : device not available for evaluation.
Event or Problem Description
It was reported that the user found a gap between the joint during the surgical change period and indicated that it may fall off.No health consequences were reported.

• Brand Name: POLARIS 100-200
• 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: 18775607
• Report Number: 9611500-2024-00075
• Device Sequence Number: 20403429
• Product Code: FTD
• UDI-Device Identifier: 04048675268109
• UDI-Public: (01)04048675268109(11)191008(93)G16980-30
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: G16980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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