MAUDE Adverse Event Report: KARL STORZ SE & Co. KG C-MAC Video Laryngoscope D-BLADE

Model Number	8404HX
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: accordingly, we would like to give a summary of our results regarding the reported issue.The evaluation results: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer "intubation failure / no illumination." was confirmed, and further defects were detected.In total the following defects were detected: ·led does not illuminate.·blade visually worn.·adhesive joints on the camera head worn.As stated, the device passed the quality check at the time of delivery.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 causes moisture to penetrate the blade, which affects electronics components and dims light.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC Video Laryngoscope D-BLADE
• Common Device Name: C-MAC Video Laryngoscope 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: theresa mussaw ; 2151 e grand ave; el segundo, CA 90245 ; +1(410)441-1327
• MDR Report Key: 50675843
• Report Number: 9610617-2026-02121
• Device Sequence Number: 5253421
• Product Code: CCW
• UDI-Device Identifier: 04048551441862
• UDI-Public: 04048551441862
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 8404HX
• Device Catalogue Number: 8404HX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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