MAUDE Adverse Event Report: PLEXUS ELECTRONICA S. DE R.L. DE C.V. MCGRATH MAC; LARYNGOSCOPE, RIGID

Model Number	301-000-000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa: 624392.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that prior to use, the videolaryngoscope's display was not showing anything even after replacing the battery.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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.
Event or Problem Description
According to the reporter, prior to use, the videolaryngoscope's display was not showing anything even after replacing the battery.There was no reported patient harm.

• Brand Name: MCGRATH MAC
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): PLEXUS ELECTRONICA S. DE R.L. DE C.V.; paseo del norte no. 4640; guadalajara technology park; zapopan,jal 45010 ; MX 45010
• Manufacturer (Section G): PLEXUS ELECTRONICA S. DE R.L. DE C.V.; paseo del norte no. 4640; guadalajara technology park; zapopan,jal 45010 ; MX 45010
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21471387
• Report Number: 3010244187-2025-00450
• Device Sequence Number: 8658982
• Product Code: CCW
• UDI-Device Identifier: 10884521776494
• UDI-Public: 10884521776494
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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: 301-000-000
• Device Catalogue Number: 301-000-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown