MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #2

Model Number	8404KXC
Medical Device Problem Codes	No Display/Image (1183); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image blocks out.No patient or procedure involvement.No negative impact in state of health reported.
Additional Manufacturer Narrative
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 "image blocks out - prior to use" was not confirmed.The device passed quality control at the time of delivery.The following conclusion has been reached based on the defects identified during the technical inspection.The fault described by the customer could not be reproduced.The defects identified during the investigation are due to usage errors or/and wear.For this reason, a user misuse error is to be assumed which led to image blocks out.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.This event is filed under internal complaint id (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #2
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MAC #2
• 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: 22311178
• Report Number: 9610617-2025-01079
• Device Sequence Number: 8794196
• Product Code: CCW
• UDI-Device Identifier: 04048551442159
• UDI-Public: 04048551442159
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 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: 8404KXC
• Device Catalogue Number: 8404KXC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 02/16/2026
• 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