MAUDE Adverse Event Report: MEDLINE RENEWAL GLIDESCOPE SPECTRUM LARYNG BLAD LOPRO2.5

Catalog Number	2700962RH
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, multiple blades were attempted to be used during intubation but displayed a blurry picture.
Additional Manufacturer Narrative
It was reported that multiple blades were attempted to be used during intubation but displayed a blurry picture.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Brand Name: GLIDESCOPE SPECTRUM LARYNG BLAD LOPRO2.5
• Common Device Name: GLIDESCOPE SPECTRUM LARYNG BLAD LOPRO2.5
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: meghana maddilli ; 3 lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25344089
• Report Number: 3032391-2026-00022
• Device Sequence Number: 18701690
• Product Code: CCW
• UDI-Device Identifier: 10193489032222
• UDI-Public: 10193489032222
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K012667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2026

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
• Device Catalogue Number: 2700962RH
• Device Lot Number: S4-547674
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Unknown