MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEOLARYNG.MAC#4

Model Number	8401BXC
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the image turned off during the procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: it is not possible to determine which product is responsible for the image failure without returning the products.Only one product can be responsible, but it is also possible that two or all products are responsible.The investigations carried out did not reveal any cause related to the labeling, the device, or its history.All production-related quality checks were passed, and no nonconformities were found in the device's manufacturing records.It was determined that the labeling contains appropriate instructions and warnings the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC VIDEOLARYNG.MAC#4
• Common Device Name: C-MAC VIDEOLARYNG.MAC#4
• 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: 21560947
• Report Number: 9610617-2025-00405
• Device Sequence Number: 17236932
• Product Code: CCW
• UDI-Device Identifier: 04048551002438
• UDI-Public: 04048551002438
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 06/10/2026

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: 8401BXC
• Device Catalogue Number: 8401BXC
• Device Lot Number: 25387
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: Not provided; 08/29/2025; 06/02/2026
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/17/2025; 09/09/2025; 06/10/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8402X,ELECTRONIC MODULELOT: OV6435; 8403ZX,C-MAC MONITOR FOR CMOS ENDOSCOPESLOT: OV12; ARTICLE: 8403ZX.ARTICLE: 8402X.
• Patient Sex: Unknown