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

Model Number	8404ZX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the monitor freezes a few seconds during intubation and the freeze is followed by a restart of the equipment.After the restart the procedure can continue and be completed.This error has not resulted in any adverse events." no negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
As the product was not returned for inspection, more detailed investigation is not possible.As already mentioned, the device passed the quality test at the time of delivery.The ifu states that the product must be checked for functionality before use, which would have prevented this fault.If there is new or additional relevant information, we will reopen the investigation accordingly.The event is filed under internal karl storz complaint id: (b)(4).
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
Investigation results: during the technical inspection by the manufacturer, the fault description provided by the customer could not be reproduced and therefore was not confirmed.The following defect was identified: · rear part of housing damaged the fault reported by the customer could not be identified.It is not possible to determine how the fault occurred.The damaged rear part of the housing identified during the investigation cannot be the cause of the fault.Based on the customer's description of the fault, we assume that it was caused by user error, as the ifu states that the product must be checked for functionality before use, which would have prevented this fault.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the software crash was traced to a runtime error that occurred while loading a script.Restarting the system resolved the issue, which explains why the problem did not reoccur during the examination of the monitor.It remains possible that another component in the imaging chain triggered the freezing event.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information: as the product was not returned for inspection, more detailed investigation is not possible.As already mentioned, the device passed the quality test at the time of delivery.Based on the customer's description of the fault, we assume that it was caused by user error, as the ifu states that the product must be checked for functionality before use, which would have prevented this fault.If there is new or additional relevant information, we will reopen the investigation accordingly.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 90245
• MDR Report Key: 22384394
• Report Number: 9610617-2025-01132
• Device Sequence Number: 8700254
• Product Code: CCW
• UDI-Device Identifier: 04048551432778
• UDI-Public: 04048551432778
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/19/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 10/07/2025; 11/03/2025; 01/16/2026; 03/30/2026; 06/18/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/30/2025; 10/09/2025; 11/05/2025; 02/09/2026; 04/01/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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