MAUDE Adverse Event Report: KARL STORZ SE & Co. KG C-MAC S Imager

Model Number	8403XSI
Medical Device Problem Codes	Mechanical Problem (1384); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: during a procedure yesterday, the device switched off.There was an intermittent electrical/contact failure while the video system was being used in an emergency situation.The procedure was completed successfully but medical, surgical, or diagnostic intervention was required.No adverse consequences reported.
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).

• Brand Name: C-MAC S Imager
• Common Device Name: C-MAC S Imager
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 50008561
• Report Number: 2020550-2026-01715
• Device Sequence Number: 5940285
• Product Code: CCW
• UDI-Device Identifier: 04048551408315
• UDI-Public: 04048551408315
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2026
• Report Date (Section F): 07/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8403XSI
• Device Catalogue Number: 8403XSI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown