MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC® POCKET MONITOR

Model Number	8403XD
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2025
Type of Reportable Event	Death
Event or Problem Description
According to the information received, image dropouts.It was confirmed by doctor that the patient had already died by the time paramedic team arrived, but attempts were still made to secure the airway.Date of death is unknown.Doctor/paramedic confirmed that the device failure neither caused nor contributed to the patient's death.Appropriate replacement equipment was available at the time of use.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.It was confirmed that the device failure neither caused nor contributed to the patient's death.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC® POCKET MONITOR
• Common Device Name: C-MAC® POCKET MONITOR
• 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: 22670796
• Report Number: 9610617-2025-01307
• Device Sequence Number: 3702554
• Product Code: CCW
• UDI-Device Identifier: 04048551396032
• UDI-Public: 04048551396032
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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: 8403XD
• Device Catalogue Number: 8403XD
• 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: 07/18/2025
• Initial Report FDA Received Date: 07/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 8404BXCSN: (B)(6).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown