MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIVERSAL CYSTO-URETHROSCOPE, 20 FR.

Model Number	27035BB
Medical Device Problem Codes	Solder Joint Fracture (2324); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the telescope presents leaks at the lens tip and the image became blurry.It was stated that the procedure was completed successfully and there were no adverse consequences for the patient, user or third.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on february 17,2025.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
Result of investigation: the returned optics we have shown mechanical damage (impact points) in the distal soldered seam.In addition, a foreign particle was detected in the rod lens system, which probably entered the image field through the impact points in the distal area.The foreign particle has no negative influence on the imaging.The optics image is sharp and clear.Identified damages: - distal end mechanically damaged - heavy impact points on the distal solder seam - moisture inside the rod lens system (this is a consequential damage due impact points on the distal solder seam) - residues inside the rod lens system (this is a consequential damage due impact points on the distal solder seam).With reference to the customer's fault description "leakage at the tip of the lens - during use," a leak can be confirmed.The leak was caused by a mechanically damaged distal solder joint (impact marks).This allowed moisture to penetrate the lens system of the imaging rod unhindered during use or clinical treatment.The ingress of moisture has a significant impact on imaging.The damage found is not due to a manufacturing/production defect but was caused by clinical use or mechanical damage.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: UNIVERSAL CYSTO-URETHROSCOPE, 20 FR.
• Common Device Name: UNIVERSAL CYSTO-URETHROSCOPE, 20 FR.
• 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: 21287056
• Report Number: 9610617-2025-00114
• Device Sequence Number: 9320126
• Product Code: FAJ
• UDI-Device Identifier: 04048551232484
• UDI-Public: 04048551232484
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K943176
• 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,Followup
• Report Date (Section B): 06/26/2025

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: 27035BB
• Device Catalogue Number: 27035BB
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 02/17/2025; 06/06/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/18/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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