MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO URETERO-RENOSCOPE FLEX-XC1

Model Number	091279-06
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device will not be returned for evaluation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross ref: (b)(4).Cross ref: (b)(4).This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that there is a green horizontal line flickering occurring right when the scope is first plugged in.Sometimes it gets so bad where the green horizontal lines become a flash disruption of the image.This has happened to multiple scopes and some have worse flickering or flashing of the image.At times it ends up where the scope completely dies and it goes back to the blue dashboard screen.They tried different camera boxes and different tc028 adapters.The symptoms persisted and it's occurring to another facility with similar lot code.They were able to complete the procedure after opening a new scope which was a reusable one instead of a disposable scope.No negative impact in state of health reported.Cross ref: complaint id: (b)(4).Cross ref: complaint id: (b)(4).
Additional Manufacturer Narrative
Correction in section h5 yes labeled for single scope.
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 (b)(4).

• Brand Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• Common Device Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22005847
• Report Number: 1221826-2025-00814
• Device Sequence Number: 9043058
• Product Code: FGB
• UDI-Device Identifier: 04048551428030
• UDI-Public: 04048551428030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

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: 091279-06
• Device Catalogue Number: 091279-06
• Device Lot Number: 202412161
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: Not provided; 09/25/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 05/12/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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