MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID

Model Number	340-000-000
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa: 624392.D10 concomitant product: 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#: 8068505); 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#: h21082004); 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#: h22081904); 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#: h22042504); 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#: h20121404); 340-000-000, mcgrath 3.6v battery 340-000-000 (lot#: h21091104).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, the videolaryngoscope showed four small squares, and the screen did not appear or turn on when the battery in question was used.The battery was replaced and the handle was power cycled, but the issue remained.There was no patient involvement.The six additional batteries showed the same failure, and it was unknown if there was patient involvement at the time of the reported event.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The battery was t ested, the and the issue was replicated.The battery did not power on the device.Both the display and the led did not work when the battery was in the device.After applying force to the middle part of the battery, the device would turn on.It was reported that v ideolaryngoscope showed four small squares, and the screen did not appear or turn on when the battery in question was used.The reported issue was confirmed.The most likely cause was traced to 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
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; UK KY11 9JE
• Manufacturer (Section G): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; UK KY11 9JE
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21526231
• Report Number: 3010244187-2025-00501
• Device Sequence Number: 9713005
• Product Code: CCW
• UDI-Device Identifier: 15060272980068
• UDI-Public: 15060272980068
• 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,Followup
• Report Date (Section B): 03/17/2026

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 Expiration Date: 11/29/2022
• Device Model Number: 340-000-000
• Device Catalogue Number: 340-000-000
• Device Lot Number: H21082004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown