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

Model Number	IPN049332
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "i literally just opened the blade to hand it to the crna to intubate and it snapped off.The handle was completely normal and it didn't look like there were any defects.When i opened the next mac 3 blade and put it on the same handle there was no issue".No patient involvement reported.
Event or Problem Description
It was repored "i literally just opened the blade to hand it to the crna to intubate and it snapped off.The handle was completely normal and it didn't look like there were any defects.When i opened the next mac 3 blade and put it on the same handle there was no issue".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The complaint sample is not available for return; however, the customer did return two photos for inspection.Visual inspection of the photos confirmed that the blade was broken.A portion of the blade that would mount on to a handle was separated from the blade.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The complaint was able to be confirmed by the returned customer photos.However, the complaint sample is not available for return.Functional testing and investigation activities cannot be conducted.The complaint root cause cannot be established.

• Brand Name: RUSCH POLARIS FO BLADE MAC 3
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11437377
• Report Number: 3011137372-2021-00050
• Device Sequence Number: 4523330
• Product Code: CCW
• UDI-Device Identifier: 14026704629692
• UDI-Public: 14026704629692
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN049332
• Device Catalogue Number: 4150130
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE; HANDLE