MAUDE Adverse Event Report: AMBU A/S ASCOPE¿ 4 CYSTO; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	601101000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Ambu 4 flexible cystoscope failure - working port unable to be used.Nothing passes through the port.

• Brand Name: ASCOPE¿ 4 CYSTO
• Common Device Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): AMBU A/S; 6721 columbia gateway drive; suite 200; columbia MD 21046
• MDR Report Key: 25825187
• Report Number: 25825187
• Device Sequence Number: 21421584
• Product Code: FAJ
• UDI-Device Identifier: 05707480157709
• UDI-Public: (01)05707480157709
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/13/2026
• Report Date (Section F): 07/13/2026

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: 601101000
• Device Catalogue Number: 601101000
• Device Lot Number: 2000023624
• 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: 07/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Date Report Sent to FDA: 07/13/2026