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

Model Number	8404ZX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
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.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that there was dim light during use.Another blade was opened and used with success.No negative impact in state of health reported.
Additional Manufacturer Narrative
Adding additional information in section b5: cross reference complaint id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Cross reference mdr: 9610617-2025-00680 and 9610617-2025-00687.
Additional Manufacturer Narrative
Result of investigation: the product (8404zx - c-mac monitor for cmos endoscopes - serial number (b)(6) was not returned for investigation.A review of the complaint history revealed that the highest probability a leak in the adhesive on the tip is the cause of the poor light output.The device passed the quality check at the time of delivery.The most likely cause of the described defect is worn of the adhesive on the tip of the c-mac blade, which was caused by wear during use and by the reconditioning process.The wear of the adhesive causes liquid to penetrate the blade, which affects the electronics and results in poor light output.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
No faults were found during the technical inspection of the 8404zx monitor, and the correct c-mac video laryngoscope was identified, which explained the low light output.Returned date information received on 08/27/2025 added to this mdr 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: 21905787
• Report Number: 9610617-2025-00684
• Device Sequence Number: 11777082
• Product Code: CCW
• UDI-Device Identifier: 04048551432778
• UDI-Public: 04048551432778
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/09/2025

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: 8404ZX
• Device Catalogue Number: 8404ZX
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 07/17/2025; 08/27/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/06/2025; 08/01/2025; 09/09/2025
• 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