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

Model Number	11278VS
Medical Device Problem Codes	Circuit Failure (1089); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that scope stopped working during the procedure lost vision.Procedure was completed successfully with another, disposable scope.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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: during the technical investigation of the returned product, the following was found: the contacts of the power connector are damaged.The housing shows signs of impact damage.There are residues on the cock housing.The shows no image, no light and no button function.The error described by the customer " stopped working during the procedure " could be confirmed.The loss of image was present during product evaluation and the condition persisted during this investigation.No image was observed when a new imager was connected, nor when a new cable was installed.Image and light functionality were restored when the current scope components were connected to a known-good pcb.No visible damage was observed on the current pcb; however, it is a reclaim component.The cause of the image failure was determined to be caused by a defective pcb.A two-year trend analysis of service records indicates a 0.2% failure rate, which is considered low for the product family.The chart below shows failures plotted by production date.Given that the device has been in the field for nearly two years with low occurrence, no increase in trend, and no clustering by build date, the failure mode does not indicate a systemic or emerging issue.For this reason, cause traced to component failure is to be considered which led to the missing image.The event is filed under internal karl storz complaint id:(b)(4).

• Brand Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Common Device Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• 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: 22554032
• Report Number: 9610617-2025-01185
• Device Sequence Number: 9576486
• Product Code: FGB
• UDI-Device Identifier: 04048551344408
• UDI-Public: 04048551344408
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141250
• 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): 01/21/2026

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: 11278VS
• Device Catalogue Number: 11278VS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 01/21/2026
• 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