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

Model Number	350-017-000
Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.Seventy one mcgrath two blades were received for evaluation.Visual inspection found 66 blades were unopened, 5 blades had been opened prior to receipt.Functional testing included testing of the returned blades.Each blade was individually connected to a test mcgrath unit (cl-16059).Each blade clipped to the unit properly and showed no sign of damage.No excessive glare was found with the blades.Each of the blades went through anti-fog testing.Each blade passed testing, providing a clear image of line pairing.No presence of condensation was found on the prism of the blades during testing.Additional product sample was not returned to the product analysis laboratory; however, a picture/video was provided by the customer for analysis.The sample met specification as received.A visual inspection of the returned photos noted:the packaging and the device was not shown.With the photo evidence provided, there is no confirmation of any defects for the reported condition.It is advised to return the device sample to the product analysis lab so that a detailed analysis can be performed.Based on the evidence available the reported condition of damaged - water/liquid was not confirmed, however, the device sample will need to be further evaluated and tested in the lab with lab equipment.Twenty additional blades were received for evaluation.Functional testing included testing of the returned blades.The blades were put onto the test mcgrath (cl-16058), one by one, and the it was reported that prior to use, there was fog seen on the size 2 blade of the device.It was then used with difficulty on a 3 year old child, which on exposure, the appearance of the mist made it impossible to visualize the glottis and did blind intubation.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 gu idance 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, prior to use, there was fog seen on the size 2 blade of the device.It was then used with difficulty on a 3 year old child, which on exposure, the appearance of the mist made it impossible to visualize the glottis and did blind intubation.There was no reported patient outcome.

• 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: 20397617
• Report Number: 3004209178-2024-19927
• Device Sequence Number: 3579102
• Product Code: CCW
• UDI-Device Identifier: 10884521824331
• UDI-Public: 10884521824331
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• 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: 01/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• 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 Age: 3 YR
• Patient Sex: Unknown