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

Model Number	11272C1
Medical Device Problem Codes	Fracture (1260); Chemical Problem (2893)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported the sheath of the device broke.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the device in question (11272c1 cysto-urethro-fiberscope, serial number: (b)(6), manufactured march 14, 2024) was received by the manufacturing site in germany for investigation on october 10, 2025.Investigation of the device revealed that the shaft's marking rings are discoloured and the sheathing of the shaft is brittle and torn in several places.In addition, the eyecup has white spots.According to the product history review the device was not repaired or maintained until today.Quality test was passed at the time of delivery.In the past, a reprocessing and information checklist provided by the customer was evaluated for similar complaints with similar failure description.The reason for the burst of the shaft, in earlier similar complaints, was due to non-compliant reprocessing.According to the investigation the failure can be traced back to a reprocessing failure.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Common Device Name: CYSTO-URETHRO-FIBERSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION INC; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDVISON INC; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23553697
• Report Number: 1221826-2025-02005
• Device Sequence Number: 13091982
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 04048551226100
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 11272C1
• Device Catalogue Number: 11272C1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown