MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO SU MEDIUM HANDLE; LARYNGOSCOPE, RIGID

Catalog Number 44402

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "crna tested connection before intubating and a crack started near the pin on the plastic".No patient involvement reported.

Manufacturer Narrative

(b)(4).The customer returned one opened rusch polaris fo su medium handle (44402) with its packaging for evaluation.Visual inspection did not reveal any defects or anomalies.Functional inspection was performed in order to recreate the product's intended use.The instructions provided on the label of this device state, "check functionality by pressing the led (can also be check wile handle is still in packaging).Mount blade and click into place.Lift blade and verify illumination." a lab inventory emerald rusch miller 2 blade was attached to the returned handle.When the blade was attached, the led was working properly.The manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.A review of the declaration of conformity (doc) and dhr found that the handle passed all the release criteria.The device was released in 05/2020 and is less than one year old.The complaint of a broken handle could not be confirmed by a complaint investigation of the returned sample.There were no defects observed with the handle.Functional inspection revealed a lab inventory blade was able to be attached to the returned handle.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported "crna tested connection before intubating and a crack started near the pin on the plastic".No patient involvement reported.

• Brand Name: RUSCH POLARIS FO SU MEDIUM HANDLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11342665
• MDR Text Key: 232359213
• Report Number: 3011137372-2021-00022
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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 Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 44402
• Device Lot Number: 205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.