MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #3

Model Number	8403AXC
Medical Device Problem Codes	Loss of or Failure to Bond (1068); No Display/Image (1183); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
According to the information received, a patient was intubated with the c-mac device as planned.The device was used without any problems earlier in the morning.The device was then washed in the equipment maintenance, after which it was brought back to the room to be charged.The device was switched on as normal, and the power cord was plugged in.The image disappeared momentarily a few times but returned as normal.Just before the next intubation began, the image on the video laryngoscope became very dark, so-called negative, i.E.The colors were dark and purple.The device was unusable at that time.It was an rsi intubation.No time to change to a new device.Intubated without an image like a normal laryngoscope.After the situation, the device was restarted, so the image was still unusable.No death or (unanticipated) serious deterioration 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.Concomittant products : 8403zx - sn: (b)(6) - c-mac monitor for cmos endoscopes.8403x - c-mac connecting cable.Et27-30-0004695 - power supply for c-mac monitor 8403zx.Returned on : 16-jan-2026.Preliminary investigation: no failure - work as intended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #3
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MAC #3
• 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: 24179414
• Report Number: 9610617-2026-00128
• Device Sequence Number: 9486497
• Product Code: CCW
• UDI-Device Identifier: 04048551389478
• UDI-Public: 04048551389478
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 06/18/2026

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: 8403AXC
• Device Catalogue Number: 8403AXC
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/04/2026; 06/16/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/20/2026; 06/18/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8403X; 8403ZX - SERIAL NUMBER: (B)(6).; ET27-30-0004695
• Patient Sex: Unknown