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

Model Number	27002L
Medical Device Problem Codes	Optical Problem (3001); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The 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 during use, the image was found to be blurry and unclear.After wiping the lens and redoing the white balance, the fault still remained.The surgery was completed by using another endoscope.The prolongation due to the malfunction was between 15 and 20 minutes.No negative impact in state of health reported.

• 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: 24498296
• Report Number: 9610617-2026-00417
• Device Sequence Number: 10115260
• Product Code: FGB
• UDI-Device Identifier: 04048551231265
• UDI-Public: 04048551231265
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/16/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/16/2026
• 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