MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE; CYSTO-URETHRO-FIBERSCOPE

Model Number	11272C1
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that there was an issue with the front cover of the product (defective).Infections occurred several times after endoscopy.Due to the reported possible infections (causality not confirmed) the risk for serious deterioration in state of health is not negligible.

• Brand Name: FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE
• Common Device Name: CYSTO-URETHRO-FIBERSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 18375032
• Report Number: 2020550-2023-00399
• Device Sequence Number: 7712970
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 4048551226100
• 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): 12/21/2023
• Report Date (Section F): 12/21/2023

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: 12/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2023
• 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