MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MAC 5; LARYNGOSCOPE, RIGID

Model Number	IPN915504
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during intubation, the light went out.We always have access to regular blades mac 4.In this case, the blades were changed." no patient injury, harm, or consequence reported.Patient condition reported as "doing well." associated mdr 3011137372-2022-00200.
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.Then a load was applied to the blade and handle using a weight scale as the customer complaint stated that the light did not illuminate once force was applied to it.The blade was applied a continuous force of up to approximately 6lbs and the light did not turn off at any point.There were no visual signs of any light deficiency within the blade.This testing was performed with an additional lab inventory handle to confirm the results.Testing with the second lab inventory handle also revealed proper light function of the returned blade.The manufacturing dhr file was reviewed based on the lot reported.No recorded results of manufacturing issues or anomalies were reported.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 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: "during intubation, the light went out.We always have access to regular blades mac 4.In this case, the blades were changed." no patient injury, harm, or consequence reported.Patient condition reported as "doing well." associated mdr 3011137372-2022-00200.

• Brand Name: RUSCH POLARIS FO BLADE MAC 5
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15651378
• Report Number: 3011137372-2022-00201
• Device Sequence Number: 20393522
• Product Code: CCW
• UDI-Device Identifier: 14026704711847
• UDI-Public: 14026704711847
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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
• Device Model Number: IPN915504
• Device Catalogue Number: 4150130
• Device Lot Number: 2008004
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: HANDLE.; HANDLE.
• Patient Sex: Unknown