MAUDE Adverse Event Report: AMBU A/S ASCOPE¿ 4 RHINOLARYNGO SLIM; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Model Number	510101000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Np [nasopharyngeal] scope camera brought with ent [ear nose throat] md when placed into screen briefly showed clear view, however, then lost connection during procedure giving error "video pipeline failed to start.Disconnect visualization device(s).Consider rebooting the system if the problem persists".Attempted to re-boot screen, disconnected camera, and also plugged and re-plugged power supply.All troubleshooting attempts met with same error.Tried on ed [emergency department] ambu scope screen with same error.New scope obtained from ed supply, and this functioned appropriately.

• Brand Name: ASCOPE¿ 4 RHINOLARYNGO SLIM
• Common Device Name: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): AMBU A/S; 6721 columbia gateway drive; suite 200; columbia MD 21046
• MDR Report Key: 23082916
• Report Number: 23082916
• Device Sequence Number: 18658052
• Product Code: EOB
• UDI-Device Identifier: 05707480157730
• UDI-Public: (01)05707480157730
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/16/2025
• Report Date (Section F): 09/16/2025

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: 510101000
• Device Catalogue Number: 510101000
• Device Lot Number: 2000014351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Date Report Sent to FDA: 09/16/2025