MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC MONITOR FOR CMOS ENDOSCOPES

Model Number	8404ZX
Medical Device Problem Codes	Device Reprocessing Problem (1091); Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported: there is difficulty to view the image on the cmac monitor.The light intensity on the cmac monitor appears to be very dim.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
Investigation: the device was sent to the manufacturer for inspection.During the technical inspection by the manufacturer, the fault description provided by the customer ("difficulty to view the image/light dim") was confirmed and further defects were identified.The following defects were identified in total: · start screen does not appear · control board defective · display defective the technical inspection determined that the display and the control board are defective, which is the cause of the poor image quality and the low brightness described by the customer.We assume this was caused by improper handling during refurbishment or by the user.The ifu states that the product must be tested for damage and functionality before use; had this been done, the defect would have been noticed, and the incident could have been avoided.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC MONITOR FOR CMOS ENDOSCOPES
• Common Device Name: C-MAC MONITOR FOR CMOS ENDOSCOPES
• 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
• MDR Report Key: 23770496
• Report Number: 9610617-2025-02303
• Device Sequence Number: 13197391
• Product Code: CCW
• UDI-Device Identifier: 04048551432778
• UDI-Public: 04048551432778
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• 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): 04/21/2026

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: 8404ZX
• Device Catalogue Number: 8404ZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/21/2026
• 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