MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) MCGRATH MAC; LARYNGOSCOPE, RIGID

Model Number	350-005-000
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during use, the video laryngoscope's screen was foggy using the reported blade.The anti-fog coating was not applied properly, so it was hard to see the screen.The lens itself was fine.The blade was replaced.There was no patient injury.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted swirling marks at both sides of the viewing prism surface on the received mcgrath blade.The blade was then connected to a test mcgrath with no issues in fit.However, the camera's view was clearly obstructed by the markings on the blade.To verify whether the anti-fog coating was applied, the mcgrath was then installed in a cap for a beaker filled with water, where in-air temperature was heated to approximately 35 degrees celsius as measured using a dmm (cl-15217) for anti-fog testing.No condensation was found on the blade prism immediately after removal of the mcgrath from the beaker cap.It was reported that the video laryngoscope's screen was foggy using the reported blade.The anti-fog coating was not applied properly, so it was hard to see the screen.The lens itself was fine.The reported issue was confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MCGRATH MAC
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21334858
• Report Number: 9681384-2025-00134
• Device Sequence Number: 20942840
• Product Code: CCW
• UDI-Device Identifier: 10884521824317
• UDI-Public: 10884521824317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: 350-005-000
• Device Catalogue Number: 350-005-000
• Device Lot Number: 24J0059JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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
• Patient Sex: Unknown