MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC® S IMAGER FOR USE WITH 8403ZX

Model Number	R8403XSI
Medical Device Problem Codes	Device Reprocessing Problem (1091); Optical Problem (3001)
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 light is defective, no light illumination.No procedure or patient 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: the product was sent to the manufacturer for examination.The technical examination confirmed the fault described by the customer.The damage identified by the manufacturer is attributable to improper use during processing or by the user.The damaged camera insert and a leak caused by excessive force are the cause of the fault described by the customer.This event is filed under internal complaint id (b)(4).

• Brand Name: C-MAC® S IMAGER FOR USE WITH 8403ZX
• Common Device Name: C-MAC® S IMAGER FOR USE WITH 8403ZX
• 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: 22176221
• Report Number: 9610617-2025-01006
• Device Sequence Number: 7788687
• Product Code: CCW
• UDI-Device Identifier: 04048551408315
• UDI-Public: 04048551408315
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 12/02/2025

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: R8403XSI
• Device Catalogue Number: R8403XSI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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