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

Model Number	8403ZX
Medical Device Problem Codes	No Display/Image (1183); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 blacked out mid intubation.It was confirmed that the procedure was completed successfully with a delay of less than 15 minutes and there were no adverse consequences reported.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the concerned monitor (article: 8403zx, serial: (b)(6), manufacturing date: 26.May 2014) was returned to the manufacturer and investigated.Upon investigation the reported issue could be confirmed.The following defects were observed during inspection: front of housing damaged, back of housing damaged, front nut video input damage, warranty seal broken, device does not start, cannot be switched on based on the damages found on the device, it is concluded that the device was handled improperly.The observed damages indicate that either it was attempted by a third party to open and repair the monitor, or the monitor was dropped or somehow mechanically damaged.This damaged the monitor and the housing, rendering the device inoperable.The investigations did not reveal a root cause related to the labelling, the device, or its history.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, 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: 22212655
• Report Number: 9610617-2025-01011
• Device Sequence Number: 12795095
• Product Code: CCW
• UDI-Device Identifier: 04048551337912
• UDI-Public: 04048551337912
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/16/2025

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: 8403ZX
• Device Catalogue Number: 8403ZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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