MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #2

Model Number	8404KXC
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the light source was dim and failing.No patient or procedure involvement.No negative impact in state of health reported.
Additional Manufacturer Narrative
The investigation is not yet completed, investigation results are pending.This event is filed under internal complaint id: (b)(4).
Additional Manufacturer Narrative
Manufacturer's evaluation results: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer was confirmed.The device passed the quality check at the time of delivery the technical examination of the video laryngoscopes revealed several user-induced defects that led to a failure of the light output.Due to damage to the blade, and a leak between the plug and the cover, liquid can penetrate the interior of the housing where the electronics are located.This damages the circuit board due to a short circuit, which impairs the function responsible for light transmission and leads to a failure of the light output.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.This event is filed under internal complaint id (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #2
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MAC #2
• 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 ; 4242188247
• MDR Report Key: 22053285
• Report Number: 9610617-2025-00890
• Device Sequence Number: 5343286
• Product Code: CCW
• UDI-Device Identifier: 04048551442159
• UDI-Public: 04048551442159
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 8404KXC
• Device Catalogue Number: 8404KXC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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