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

Catalog Number 4150130

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: the light was flickering prior to use on a patient.The issue was detected in the clinical setting.No patient involvement.

Event Description

The complaint is reported as: the light was flickering prior to use on a patient.The issue was detected in the clinical setting.No patient involvement.

Manufacturer Narrative

(b)(4).The customer returned one rusch polaris fo blade mac 3.Upon receipt, the blade was visually inspected.No obvious signs of damage were observed.It was noted that the returned blade was fiber optic meaning that no light bulb was present in the blade to cause flickering.This type of blade is to be used with a handle that contains a light bulb.The fiber optic bundle on the blade then redirects the light from the handle to the distal end of the blade.The returned blade was placed on a teleflex rusch dispoled handle to functionally test.The blade was connected to the handle without any resistance and was engaged.No flickering was observed when connected to the lab inventory handle.The light transfer through the fiber optic bundle was successful with no visual signs of light deficiency.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.

• Brand Name: RUSCH POLARIS FIBER OPTIC BLADE MAC 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10649105
• MDR Text Key: 210416997
• Report Number: 3011137372-2020-00226
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Catalogue Number: 4150130
• Device Lot Number: AB2002002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 11/03/2020
• Patient Sequence Number: 1
• Treatment: DAHLHAUSEN LARYNGOSCOPE HANDLE; DAHLHAUSEN LARYNGOSCOPE HANDLE; DAHLHAUSEN LARYNGOSCOPE HANDLE