MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #0

Model Number	8404EXC
Medical Device Problem Codes	Device Reprocessing Problem (1091); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is not yet completed, investigation results are pending.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported the light is very low and image is dark.No patient or procedure involvement.No negative impact in state of health reported.
Additional Manufacturer Narrative
Manufacturer's evaluation results: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description "the light is very low and image is dark" was confirmed, and further defects were detected.The device has not been repaired or maintained until now.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 most likely cause for the described error is the wear of the adhesive at the tip of the c-mac blade, coming from wear and tear during use and the reprocessing process.The wear of the adhesive causes liquid to penetrate the blade, which affects the electronics and causes the light is weak.This event is filed under internal complaint id (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #0
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MAC #0
• 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: 22849118
• Report Number: 9610617-2025-01418
• Device Sequence Number: 14543443
• Product Code: CCW
• UDI-Device Identifier: 04048551441992
• UDI-Public: 04048551441992
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 12/18/2025

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: 8404EXC
• Device Catalogue Number: 8404EXC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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
• Patient Sex: Unknown