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

Model Number	8403AXC
Medical Device Problem Codes	Device Reprocessing Problem (1091); Output Problem (3005)
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 "light not working, upon receipt noticed that cover glass missing on blades." no negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: several defects were identified during the manufacturer's technical inspection.The investigation revealed that all three products were manufactured in 2019 and had never been repaired or serviced since then.Intensive use over several hours and hundreds of applications causes wear and tear on the product, and the adhesive that holds the cover glass in place can also wear out, which can only be remedied by maintenance or repair.Wear and tear on the adhesive can allow liquid to penetrate the interior of the housing and damage the electronics responsible for light and image.Due to several instances of damage to the products, we assume that the product has been used improperly.Improper refurbishment can also cause damage to the housing and adhesive, which can lead to failure of the cover glass and malfunction of the lighting and imaging.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: 21999889
• Report Number: 9610617-2025-00809
• Device Sequence Number: 7109401
• Product Code: CCW
• UDI-Device Identifier: 04048551389478
• UDI-Public: 04048551389478
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/23/2025

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: 8403AXC
• Device Catalogue Number: 8403AXC
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 10/16/2025
• Initial Report FDA Received Date: 05/11/2025
• Supplement Report FDA Received Date: 05/21/2025; 10/23/2025
• 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