MAUDE Adverse Event Report: KARL STORZ SE & Co. KG C-MAC Video Laryngoscope MIL #0

Model Number	8404DXC
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/07/2026
Type of Reportable Event	Death
Event or Problem Description
The following was reported: patient was born at 33+4 weeks gestation.Following admission to the neonatal unit for prematurity and observation, the infant developed increasing respiratory distress, oxygen requirement and respiratory acidosis.Despite non-invasive respiratory support, the patients oxygen requirement remained around 30% and chest x-ray was consistent with surfactant lung disease deficiency.The clinical team therefore decided to proceed with less invasive surfactant administration using karl storz video laryngoscope.Attempts by different doctors were made to visualize the airway using video laryngoscope but difficulties were encountered with airway visualization, including reports of a dark video screen.The procedure was subsequently completed using a conventional laryngoscope.Shortly after the procedure, patient experienced sudden clinical deterioration with a significant right-sided tension pneumothorax identified.Emergency needle thoracocentesis and subsequent chest drains were unable to improve patients condition, and patient died.The concern is that poor visualization using the karl storz video laryngoscope hindered successful lisa administration, and potentially inserting the catheter without visualization has caused trauma leading to tension pneumothorax.

• Brand Name: C-MAC Video Laryngoscope MIL #0
• Common Device Name: C-MAC Video Laryngoscope MIL #0
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen 78532
• MDR Report Key: 50861620
• Report Number: 2020550-2026-02144
• Device Sequence Number: 9553167
• Product Code: CCW
• UDI-Device Identifier: 04048551441947
• UDI-Public: 04048551441947
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8404DXC
• Device Catalogue Number: 8404DXC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8403X - C-MAC Connecting Cable; Article: 8404ZXK - C-MAC MonitorSN: (b)(6)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown