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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MCGRATH; LARYNGOSCOPE, RIGID
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MEDTRONIC SOFAMOR DANEK USA, INC MCGRATH; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 340-000-000
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/03/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 340-000-000, mcgrath 3.6v battery 340-000-000, lot# h24101104.340-000-000, mcgrath 3.6v battery 340-000-000, lot# h24101104.340-000-000, mcgrath 3.6v battery 340-000-000, lot# h24101104.340-000-000, mcgrath 3.6v battery 340-000-000, lot# h24102504.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 with the batteries, the handle turned on but there was no display not even the battery icon prior to use.When the reported batteries were replaced, the handle worked normally.There was no patient involved.
 
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Brand Name
MCGRATH
Common Device Name
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinnea road
memphis,tn
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinnea road
memphis,tn
Manufacturer Contact
mike bocchino
8200 coral sea st ne
mounds view, MN 55112-4391
8006464633
MDR Report Key24987823
Report Number3003120897-2026-00775
Device Sequence Number21445348
Product Code CCW
UDI-Device Identifier10884521824157
UDI-Public(01)10884521824157(17)261112(10)H24101104
Combination Product (Y/N)N
Initial Reporter CountryJA
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
Type of Report Initial
Report Date (Section B) 04/24/2026
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 Number340-000-000
Device Catalogue Number340-000-000
Device Lot NumberH24101104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/06/2026
Initial Report FDA Received Date04/24/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured11/12/2024
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
Concomitant Medical Products
and Therapy/Usage Dates
SEE NOTES ON H11
Patient SexUnknown
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