MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. CYSTO-URETHRO-FIBERSCOPE; FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE

Model Number	11272C1
Medical Device Problem Codes	Contamination (1120); Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred in germany.The customer reports a possible incident due to germs in the instrument.No details regarding malfunction, patient involvement, or negative impact on the state of health were reported.Further information was requested but not received at this time.Thus, in terms of caution, this case is deemed reportable.
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).
Additional Manufacturer Narrative
The initial case for this report was deemed reportable, but after the evaluation of the product, it has been concluded that there were no issues with the device.The event was re-evaluated and is considered not reportable.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Common Device Name: FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245
• Manufacturer (Section G): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 16904841
• Report Number: 1221826-2023-00098
• Device Sequence Number: 12472117
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 4048551226100
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K945185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 11272C1
• Device Catalogue Number: 11272C1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown