MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MAC 3; LARYNGOSCOPE, RIGID

Catalog Number	4150130
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "this paddle has a very short light and when a patient must be intubated, the light is not powerful enough to be able to see the larynx and intubate correctly.The issue was identified prior to use.There was no patient involvement.".
Additional Manufacturer Narrative
(b)(4).The customer returned one 4150130 rusch polaris fo blade mac 3 for investigation.Visual examination did not reveal any obvious defects or anomalies.The device appeared typical.Functional inspection was performed by attaching the blade to a known good rusch dispoled lab inventory handle.To switch on, the blade was pulled up and the blade was able to properly illuminate.The manufacturing dhr file was reviewed based on the lot reported.No recorded results of manufacturing issues or anomalies were reported.A review of the device history record found that the blade passed all necessary release criteria.The device was released in 10/2023 and is approximately 10 months old.The complaint cannot be confirmed.Functional testing confirmed that the blade was able to properly illuminate with multiple lab inventory handles attached.The returned blade was put under an applied load and the light did not turn off, dim, or flicker at any point.No issues were identified with the light function of the blade.A device history record review was performed with no relevant findings identified.Therefore, the complaint cannot be confirmed as there was no fault found with the device.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "this paddle has a very short light and when a patient must be intubated, the light is not powerful enough to be able to see the larynx and intubate correctly.The issue was identified prior to use.There was no patient involvement.".
Additional Manufacturer Narrative
(b)(4).The customer returned one 4150130 rusch polaris fo blade mac 3 for investigation.Visual examination did not reveal any obvious defects or anomalies.The device appeared typical.Functional inspection was performed by attaching the blade to a known good rusch dispoled lab inventory handle.To switch on, the blade was pulled up and the blade was able to properly illuminate.The manufacturing dhr file was reviewed based on the lot reported.No recorded results of manufacturing issues or anomalies were reported.A review of the device history record found that the blade passed all necessary release criteria.The device was released in 10/2023 and is approximately 10 months old.The complaint cannot be confirmed.Functional testing confirmed that the blade was able to properly illuminate with multiple lab inventory handles attached.The returned blade was put under an applied load and the light did not turn off, dim, or flicker at any point.No issues were identified with the light function of the blade.A device history record review was performed with no relevant findings identified.Therefore, the complaint cannot be confirmed as there was no fault found with the device.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "this paddle has a very short light and when a patient must be intubated, the light is not powerful enough to be able to see the larynx and intubate correctly.The issue was identified prior to use.There was no patient involvement.".

• Brand Name: RUSCH POLARIS FO BLADE MAC 3
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19870741
• Report Number: 3011137372-2024-00115
• Device Sequence Number: 7778455
• Product Code: CCW
• UDI-Device Identifier: 14026704629692
• UDI-Public: (01)14026704629692(11)230718(17)261015(10)AB2310006(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2024

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: 4150130
• Device Lot Number: AB2310006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 08/15/2024; Not provided
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 08/26/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown