MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC McGRATH; LARYNGOSCOPE, RIGID

Model Number	340-000-000
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction

• 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--439 ; +1(800)646-4633
• MDR Report Key: 50782173
• Report Number: 3003120897-2026-01566
• Device Sequence Number: 13389481
• Product Code: CCW
• UDI-Device Identifier: 10884521824157
• UDI-Public: (01)10884521824157(17)280316(10)H26020304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPTED
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Number: 340-000-000
• Device Catalogue Number: 340-000-000
• Device Lot Number: H26020304
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown