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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 Code No Display/Image (1183)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/25/2026
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, while preparing for use, the customer attempted to power on the videolaryngoscope and the screen started up but then went black.There was no patient involved.
 
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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 Key24794623
Report Number2936999-2026-00118
Device Sequence Number8858473
Product Code CCW
UDI-Device Identifier10884521823396
UDI-Public(01)10884521823396(11)240604(20)03
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Other,Health Professional
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/07/2026
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? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2026
Supplement Date Received by Manufacturer07/02/2026
Initial Report FDA Received Date04/06/2026
Supplement Report FDA Received Date07/07/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured06/04/2024
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
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