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); No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
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.According to the healthcare provider the product was returned to storz in august.Since then, they have a loan monitor.The same incident has happened with the loan monitor.No negative impact in state of health reported.Please send a mir for the incident with the loaner equipment with the same issue.Due to a request by the swedish competent authority, this case is now deemed reportable for sweden.Based on the above-mentioned evaluation, the reporting decision for us and row is still adequate.
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
Device evaluation: the device was sent to the manufacturer for inspection.During the technical inspection by the manufacturer, the fault description provided by the customer was confirmed and further defects were identified.The following defects were identified in total: ·battery lifetime expired ·ferrite core not fixed ·start screen does not appear ·control board defective during the technical inspection, it was determined that the product has a defective processor board, which is responsible for the imaging failure.The ifu states that the product must be checked for functionality before use.Had this been done, it would have been noticed that the product was no longer working and could have been sent in for maintenance, thus preventing the failure.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.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: 23804833
• Report Number: 9610617-2025-02332
• Device Sequence Number: 21165749
• 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
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 03/18/2026; 04/09/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 04/01/2026; 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