MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #3

Model Number	8404AX
Medical Device Problem Codes	Device Reprocessing Problem (1091); No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was "low light from led, dark picture".No patient involvement reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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).
Additional Manufacturer Narrative
Result of investigation: during the manufacturer's technical inspection, the error description provided by the customer "low light from led, dark picture " was confirmed, and further defects were detected.Based on the defects found during the technical inspection it is concluded that cause of the described error is wear of the adhesive on the tip of the c-mac blade, caused by wear during use and reprocessing.The wear of the adhesive allows moisture to penetrate the blade, which affects the electronics and can lead to a led fault.There is also a leak between plug and the cover of the c-mac blade, coming from wear and tear during use and the reprocessing process.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #3
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MAC #3
• 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: 22472398
• Report Number: 9610617-2025-01187
• Device Sequence Number: 8113061
• Product Code: CCW
• UDI-Device Identifier: 04048551441855
• UDI-Public: 04048551441855
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 8404AX
• Device Catalogue Number: 8404AX
• Device Lot Number: TM3099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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