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

Model Number	UI500
Medical Device Problem Codes	Optical Problem (3001); Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the image quality of the flexible scope is not clear during surgery.It is not a brand new scope and image quality is bad.Difficulty in doing the cystoscopy procedure.Procedure completed successfully.Spare device was used to complete procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.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).
Additional Manufacturer Narrative
Device evaluation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description "image quality is not clear" was not confirmed.A visual and functional test was carried out on the endoscope.Handgrip and housing, are in good conditions.No scratches, no wearing marks.The shaft is in good condition (no scratches or other damages).The image output is sufficient.The complained failure cannot be confirmed.Possible causes which can lead to the described error are: the cover glass was not free of stains that affect the image.Another device in the imaging chain had a malfunction that affected the image.The light output was not optimally adjusted to the surgical field, resulting in an image that was not optimal.What ultimately led to the error described by the customer cannot be determined during the investigation.The device passed the quality check at the time of delivery.In addition, customer will be informed and instructed in the instruction for use in a separate communication to observe several warnings to avoid further malfunction.This event is filed under internal complaint id (b)(4).

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Common Device Name: CYSTO-URETHRO-FIBERSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22900893
• Report Number: 1221826-2025-01475
• Device Sequence Number: 8018035
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 04048551226100
• Combination Product (Y/N): N
• Initial Reporter Country: MP
• 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): 11/18/2025

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: UI500
• Device Catalogue Number: UI500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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