MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE D-BLADE, PED.

Model Number	R8404HXP
Medical Device Problem Codes	Device Reprocessing Problem (1091); Poor Quality Image (1408); Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
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 dim.No procedure or patient involvement.No negative impact in state of health reported.
Additional Manufacturer Narrative
Per manufacturer's investigation results: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer "light is dim" 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 cause of 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 moisture to penetrate the blade, which affects electronics, and dims light.As well moisture was penetrating to camera optical system, what caused image degradation, spots, shadows.This event is filed under internal complaint id(b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE D-BLADE, PED.
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE D-BLADE, PED.
• 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: 22904358
• Report Number: 9610617-2025-01480
• Device Sequence Number: 9089169
• Product Code: CCW
• UDI-Device Identifier: 04048551441879
• UDI-Public: 04048551441879
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 03/09/2026

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: R8404HXP
• Device Catalogue Number: R8404HXP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 03/09/2026
• 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