MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC® VIDEO LARYNGOSCOPE MAC #4

Model Number	8404BX
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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "image loss" 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
Device evaluation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the fault description provided by the customer could not be confirmed.As previously mentioned, the device passed quality control at the time of shipment.During the technical inspection of the video laryngoscope, it was determined that the blade shows signs of damage and that the led is dim and flickering; however, no image defects were found.The cause of the described fault may lie in another component, such as the cable or the monitor.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC® VIDEO LARYNGOSCOPE MAC #4
• Common Device Name: C-MAC® VIDEO LARYNGOSCOPE MAC #4
• 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: 23658869
• Report Number: 9610617-2025-02177
• Device Sequence Number: 15959298
• Product Code: CCW
• UDI-Device Identifier: 04048551441930
• UDI-Public: 04048551441930
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/03/2026

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: 8404BX
• Device Catalogue Number: 8404BX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 06/03/2026
• 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