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

Model Number	8404ZX
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that the customer complained that on the c-mac monitor sometimes the image is frozen.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: during the technical inspection by the manufacturer, the fault description provided by the customer image frozen, squares appear with hdmi was confirmed and further defects were identified.The customer's reported fault was caused by a defective processor board.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, CA
• MDR Report Key: 22414022
• Report Number: 9610617-2025-01120
• Device Sequence Number: 9664479
• Product Code: CCW
• UDI-Device Identifier: 04048551432778
• UDI-Public: 04048551432778
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 8404ZX
• Device Catalogue Number: 8404ZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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