MAUDE Adverse Event Report: KARL STORZ SE & CO.KG VIDEO URETERO-RENOSCOPE FLEX-XC1

Model Number	091279-06
Medical Device Problem Codes	No Display/Image (1183); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported: the issue became apparent during the procedure when the image was experiencing some form of interference or disconnection.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further 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).
Additional Manufacturer Narrative
Conclusion summary: investigational activities suggest multiple root causes could potentially be related to image quality issues.In an effort to further investigate the potential root causes, we have initiated capa-25-0042.We will continue to track and trend image quality issues.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Correction has been made in section h2 and h3.This event is filed under internal complaint id (b)(4).

• Brand Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• Common Device Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• 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, CA 90245 ; 4242188247
• MDR Report Key: 22928166
• Report Number: 9610617-2025-01516
• Device Sequence Number: 9162391
• Product Code: FGB
• UDI-Device Identifier: 04048551428030
• UDI-Public: 04048551428030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K212458
• 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,Followup
• Report Date (Section B): 01/16/2026

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: 091279-06
• Device Catalogue Number: 091279-06
• Device Lot Number: 500123661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/16/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 12/30/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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