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

Model Number	11278VS
Medical Device Problem Codes	No Display/Image (1183); Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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).
Event or Problem Description
It was reported that the images was not shown.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: a visual and functional inspection of the endoscope was performed.The handgrip, housing, and shaft are in good condition with no visible damage.The plug shows deep scratches on the gold contacts of the ccu cable.Traces of liquid were found on the circuit board, and corrosion was present at the interface between the image connector and the pcb.The endoscope produced a distorted image, although no leakage was detected.The customer reported issue "image is not showing" could not be confirmed, but reduced image quality was observed.Evidence of internal fluid was found, despite the device being leak, tight.It is likely that fluid entered during the cleaning process, potentially due to the vent being left open.After sufficient drying time, full image functionality returned.Fluid ingress likely caused corrosion at the imager to pcb connector.Both the imager and pcb are newly manufactured components (march 2025).Additional corrosion and debris were found around the led board.After cleaning the imager connector and replacing the pcb, the image quality was restored; however, damage to the imager connector remains.As the endoscope was not leaking, the only plausible entry point for moisture is the pressure compensation valve.Therefore, user misuse is considered the likely cause of the image failure.The ifu outlines the correct handling and reprocessing of the device.Additionally, a visual and functional inspection must be performed before each use to prevent potential injury and avoid damage to the product.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 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 ave; el segundo, CA 90245
• MDR Report Key: 23633427
• Report Number: 1221826-2025-02142
• Device Sequence Number: 9317450
• Product Code: FGB
• UDI-Device Identifier: 04048551344408
• UDI-Public: 04048551344408
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/01/2026
• 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