MAUDE Adverse Event Report: VITALTEC MCGRATH MAC; LARYNGOSCOPE, RIGID

Model Number	350-017-000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.Thirteen blades were received for evaluation.Visual inspection found no notable conditions.Functional testing included testing of the returned blades with a lab handle and battery, placing devices on the lab handle camera stick, devices led emitting a visible light with an image visible on the lcd screen, the battery icon status visible and displaying properly.The lcd image quality and light output of the led were inspected and were found to be adequate.It was reported that the picture quality looked normal prior to intubation.During intubation the picture quality became "clouded/fogged." once the blade was inserted into the patient's airway the visual quality became poor.An alternate size blade from a different lot number was used and did not experience the same issue.Several size 2 blades from the same lot number were tried and experienced the same issue.The reported issue could not be confirmed.The most likely cause could not be identified, because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.This report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting guidance from fda's 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.H9: z-0168-2024; z-0169-2024 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 picture quality looked normal prior to intubation.During intubation the picture quality became "clouded/fogged." once the blade was inserted into the patient's airway the visual quality became poor.An alternate size blade from a different lot number was used and did not experience the same issue.Several size 2 blades from the same lot number were tried and experienced the same issue.There was no patient injury.

• Brand Name: MCGRATH MAC
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VITALTEC; no. 12, lane 4-30, chyuan zhou; taichung 42142 ; TW 42142
• Manufacturer (Section G): VITALTEC; no. 12, lane 4-30, chyuan zhou; taichung 42142 ; TW 42142
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20397784
• Report Number: 3004209178-2024-19931
• Device Sequence Number: 6517542
• Product Code: CCW
• UDI-Device Identifier: 10884521824331
• UDI-Public: 10884521824331
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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: 08/22/2025
• Device Model Number: 350-017-000
• Device Catalogue Number: 350-017-000
• Device Lot Number: 22082207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H11
• Patient Sequence Number: 1
• Patient Sex: Unknown