MAUDE Adverse Event Report: KARL STORZ SE & CO. KG URETERO-RENOSCOPE, 9.5 FR., 6°, 43 CM

Model Number	27002L
Medical Device Problem Codes	Poor Quality Image (1408); Improper Chemical Reaction (2952); Optical Distortion (3000)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image is foggy.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
During technical investigation the following was observed: moisture was found to have penetrated the system.The imaging is blurred due to the presence of moisture.The distal solder joint has been chemically corroded, which may have led to the leak.The damage identified is not attributable to a production or manufacturing defect but was caused by clinical use and clinical reprocessing.Appropriate warnings about the correct handling of the device and the product testing as well as precautions and warnings are included in the corresponding instructions for use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: URETERO-RENOSCOPE, 9.5 FR., 6°, 43 CM
• Common Device Name: URETERO-RENOSCOPE, 9.5 FR., 6°, 43 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24373444
• Report Number: 9610617-2026-00320
• Device Sequence Number: 5583720
• Product Code: FGB
• UDI-Device Identifier: 04048551231265
• UDI-Public: 04048551231265
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• PMA/510(K) Number: K233372
• 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): 05/05/2026

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: 27002L
• Device Catalogue Number: 27002L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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