MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MIL #1

Model Number	R8404GXC
Medical Device Problem Codes	Device Reprocessing Problem (1091); Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was dim light.No patient or procedure involvement.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device is pending receipt by manufacturer.The investigation is not yet completed.Investigation results are pending.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Device received by manufacturer as noted in section d9.The investigation is not yet completed, investigation results are pending.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per manufacturer's investigation results: 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.Based on the defects found during the technical inspection, it is concluded that the cause of the described fault is wear of the adhesive on the tip of the c-mac blade, caused by wear during use and reprocessing.The wear of the adhesive can allow liquid to penetrate the blade, which affects the electronics and can lead to a led fault.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 MIL #1
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MIL #1
• 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: 21960654
• Report Number: 9610617-2025-00788
• Device Sequence Number: 12581128
• Product Code: CCW
• UDI-Device Identifier: 04048551441978
• UDI-Public: 04048551441978
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 12/02/2025

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: R8404GXC
• Device Catalogue Number: R8404GXC
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 11/17/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/13/2025; 12/02/2025
• 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