MAUDE Adverse Event Report: KARL STORZ SE & Co. KG C-MAC Video Laryngoscope D-BLADE

Model Number	8404HX
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported: "8404hx reported with dim light, and poor image quality." no negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC Video Laryngoscope D-BLADE
• Common Device Name: C-MAC Video Laryngoscope D-BLADE
• 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: theresa mussaw ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 50481859
• Report Number: 9610617-2026-02044
• Device Sequence Number: 10396633
• Product Code: CCW
• UDI-Device Identifier: 04048551441862
• UDI-Public: 04048551441862
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 8404HX
• Device Catalogue Number: 8404HX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/27/2026
• 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