MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC MONITOR FOR CMOS ENDOSCOPES

Model Number	8403ZX
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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).
Event or Problem Description
It was reported that during bronchoscopy, screen failure, interruption and black and white images.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the evaluation results are based on the technical inspection performed and confirmed the description of the event ("during the bronchoscopy, the screen failed interruptions and black and white images") for product 8403zx, which has been identified as the lead device in this case.During the inspection, a loose connection at the rear charging socket as well as damage to the flex board were detected.These findings explain the reported behavior, as the defective socket impaired battery charging, resulting in an unstable power supply and loss of image display when the camera head was connected.Taking into account the device age and the inspection findings, the root cause is assessed as wear and tear associated with long term use.Product 8401yca was also evaluated as a concomitant device.No defects or abnormalities were identified during the technical inspection.Based on the investigation results, this product did not contribute to the reported issue.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC MONITOR FOR CMOS ENDOSCOPES
• Common Device Name: C-MAC MONITOR FOR CMOS ENDOSCOPES
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, ; GM
• 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: 23498697
• Report Number: 9610617-2025-02038
• Device Sequence Number: 8973664
• Product Code: CCW
• UDI-Device Identifier: 04048551337912
• UDI-Public: 04048551337912
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182186
• 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): 04/13/2026

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: 8403ZX
• Device Catalogue Number: 8403ZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 04/13/2026
• 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: 8401YCA,VESA 75 QUICK CLIP FOR C-MAC.
• Patient Sex: Unknown