MAUDE Adverse Event Report: KARL STORZ ENDOVISION CYSTO-URETHRO-FIBERSCOPE

Model Number	11272C1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: the customer has a faulty 11272c1 (leaking) cysto- urethro-fiberscope.Apparently, two patients developed a bladder infection, which led to the discovery that the endoscope was leaking.Due to developed bladder infection the event is deemed reportable.

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Common Device Name: CYSTO-URETHRO-FIBERSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 25117935
• Report Number: 2020550-2026-01029
• Device Sequence Number: 9326145
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 04048551226100
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026
• Report Date (Section F): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11272C1
• Device Catalogue Number: 11272C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown