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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC MCGRATH MAC; LARYNGOSCOPE, RIGID

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COVIDIEN LLC MCGRATH MAC; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 301-000-000
Medical Device Problem Codes No Display/Image (1183); Failure to Power Up (1476)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/24/2026
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.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
It was reported that a healthcare professional used the video laryngoscope during a difficult intubation and, when the handle was tu rned on, a blue screen displayed and it did not progress to the video screen.After the battery was changed, the video screen appeared but then went black during the intubation.It was further reported that the handle would not turn on.The handle was tested with known good batteries, but the issue was not resolved.The anesthetist was able to intubate without it in the end as the screen was not reliable.There was no patient injury.
 
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Brand Name
MCGRATH MAC
Common Device Name
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
COVIDIEN LLC
6135 gunbarrel ave
boulder,co
Manufacturer (Section G)
COVIDIEN LLC
6135 gunbarrel ave
boulder,co
Manufacturer Contact
mike bocchino
8200 coral sea st ne
mounds view, MN 55112-4391
8006464633
MDR Report Key25043599
Report Number2936999-2026-00151
Device Sequence Number9725698
Product Code CCW
UDI-Device Identifier10884521823396
UDI-Public(01)10884521823396(11)240206(20)03
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
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 Health Care Professional
Type of Report Initial
Report Date (Section B) 04/30/2026
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 Model Number301-000-000
Device Catalogue Number301-000-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2026
Initial Report FDA Received Date04/30/2026
Date Device Manufactured02/06/2024
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 Number1
Patient SexUnknown
Patient Weight57 KG
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