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

Model Number	8404HXP
Medical Device Problem Codes	Device Reprocessing Problem (1091); Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description "during our technical check, we observed that, when the device is turned on, the led does not provide sufficient illumination." there is no information that the event caused a harm or serious injury to patient, user or third.
Additional Manufacturer Narrative
The device in question was returned manufacturer on april 14,2025.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer "led does not provide sufficient illumination" was confirmed, and further defects were detected.In total the following defects were detected: led is dim.Blade worn.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 of the described fault is mechanical damage and wear caused during use, which has impaired the light quality and image quality the event is filed under internal karl storz 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
• MDR Report Key: 21955675
• Report Number: 9610617-2025-00767
• Device Sequence Number: 12538798
• Product Code: CCW
• UDI-Device Identifier: 04048551441879
• UDI-Public: 04048551441879
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 8404HXP
• Device Catalogue Number: 8404HXP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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