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

Model Number	8404AX
Medical Device Problem Codes	Device Reprocessing Problem (1091); Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a failure of the c-mac pocket monitor during intubation.No further information available.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).
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: there was no failure detected the software version is up to date.As it was established during the investigation that the fault complained about by the customer was due to the blades sent in with the monitor, a more in-depth investigation of the monitor is not necessary and would not lead to any new findings.The error described by the customer " failure of the c-max pocket monitor during intubation " could not be confirmed.The device passed the quality inspection at the time of delivery.Based on the defects found during the technical inspection, it is concluded that the most likely cause of the described fault is mechanical damage causing the c-mac blade to leak between the connector and the cover.The leakage causes liquid to enter the blade, which affects the electronics and thus the image.Over time, the moisture evaporates again and the spatula returns to normal image, meaning that this effect could not be detected during the investigation.This event is filed under internal complaint id (b)(4).
Event or Problem Description
Cross reference mdr: 9610617-2025-01631.9610617-2025-01632.
Additional Manufacturer Narrative
Following the completion of the investigation and the receipt of additional information, it was determined that the previously reported leading device, 8403xdk - c-mac pocket monitor, is not the primary device involved in this event.Instead, it should be classified as a concomitant medical device and has been updated accordingly in section d10.8404ax - c-mac video laryngoscope mac #3 sn: (b)(6): blade damaged.Adhesive points on camera head worn.Housing visually worn.Cover visually worn.Leak between plug and cover.Software version is up to date.8404bx - c-mac video laryngoscope mac #4 sn (b)(6): blade damaged.Housing visually worn.Cover damaged.Leak between plug and cover.Software version is up to date.8404bx - c-mac video laryngoscope mac #4 sn (b)(6): blade damaged.Worn adhesive points on the camera head.Housing visually worn.Cover visually worn.Leak between plug and cover.Software version is up to date.8403xdk - c-mac pocket monitor set sn (b)(6): there was no failure detected the software version is up to date.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: 22682569
• Report Number: 9610617-2025-01330
• Device Sequence Number: 8937610
• Product Code: CCW
• UDI-Device Identifier: 04048551441855
• UDI-Public: 04048551441855
• 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,Followup,Followup
• Report Date (Section B): 09/18/2025

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: 8404AX
• Device Catalogue Number: 8404AX
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 09/11/2025; 09/11/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/18/2025; 09/15/2025; 09/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8403XDK - C-MAC POCKET MONITOR SET SN: (B)(6).; 8404AX - C-MAC VIDEO LARYNGOSCOPE MAC #3 SN: (B)(6).; 8404BX - C-MAC VIDEO LARYNGOSCOPE MAC #4 SN: (B)(6).; 8404BX - C-MAC VIDEO LARYNGOSCOPE MAC #4 SN: (B)(6).
• Patient Sex: Unknown