MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIVERSAL-CYSTO-URETHROSCOPE, 17 FR

Model Number	27035BA
Medical Device Problem Codes	Fogging (1253); Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported the scope had blurry and bad image.The issue was detected prior procedure.No negative impact to the patient reported.
Additional Manufacturer Narrative
The customer will not return the device for evaluation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).Case (b)(4).
Additional Manufacturer Narrative
Per global evaluation findings: the device in question was not returned to karl storz tuttlingen.Therefore, a technical inspection is not possible.The 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 labelling was found to contain adequate instructions and warnings.The customer's complaint (blurry - bad image) cannot be verified at this time, as the customer did not return the item to us for a more detailed analysis of the cause.The customer states that they solved the poor imaging problem themselves.It is possible that contamination of the distal or proximal cover glass could have led to image impairment.This statement is speculative and cannot be verified at this time.No further action will be taken.This event is filed under internal complaint id (b)(4).

• Brand Name: UNIVERSAL-CYSTO-URETHROSCOPE, 17 FR
• Common Device Name: UNIVERSAL-CYSTO-URETHROSCOPE, 17 FR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo ; 4242188247
• MDR Report Key: 21209731
• Report Number: 9610617-2025-00044
• Device Sequence Number: 12766312
• Product Code: FAJ
• UDI-Device Identifier: 04048551232460
• UDI-Public: 04048551232460
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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: 27035BA
• Device Catalogue Number: 27035BA
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/25/2025; 07/07/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/25/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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