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

Model Number	8403AXC
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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).
Event or Problem Description
It was reported that cover glass is missing, bent blade.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: during the manufacturer's technical inspection of the returned, the error description provided by the customer "the small transparent lens cover (approximately 1mm) of the blade was found missing after use" was confirmed and further defects were detected.In total the following defects were detected: blade damaged adhesive joints on camera head worn missing flat glass leak housing worn cover damaged plug damaged the device passed quality control at the time of delivery.Based on the defects found during the technical inspection, it is concluded that the most likely cause of the described defect is the wear of the adhesive on the tip of the c-mac blade, which is caused by wear during use and the reprocessing process.The wear of the adhesive has caused the flat glass to fall out.The labeling contains adequate instructions to perform visual inspection of the product before and after each use.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
• 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: 22015285
• Report Number: 9610617-2025-00822
• Device Sequence Number: 8814637
• 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
• Report Date (Section B): 11/24/2025

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
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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