MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEOLARYNG. D-BLADE

Model Number	8401HX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	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 the light has poor quality.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: during the manufacturer's technical inspection of the returned device, the error description provided by the customer was - confirmed, further defects were detected.In total the following defects were detected: led is dim, blade damaged.The device passed the quality test at the time of delivery.Based on the technical inspection, the fault described by the customer was identified.The product has never been repaired or serviced since its manufacture in 2015.Therefore, wear and tear could have caused the error.During maintenance, the problem could have been found and repaired, and there would have been no failure during the operation.Furthermore, as described in the ifu, a functional test must be carried out before starting.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC VIDEOLARYNG. D-BLADE
• Common Device Name: C-MAC VIDEOLARYNG. D-BLADE
• 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: 22829161
• Report Number: 9610617-2025-01410
• Device Sequence Number: 14568667
• Product Code: CCW
• UDI-Device Identifier: 04048551251935
• UDI-Public: 04048551251935
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/11/2026

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: 8401HX
• Device Catalogue Number: 8401HX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 03/11/2026
• 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