MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC VIDEO LARYNGOSCOPE MAC #4

Model Number	8403BXC
Medical Device Problem Codes	Optical Problem (3001); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the second product involved in this event was inadvertently reported under mdr (b)(4).(b)(4).This mdr is to create an initial report for the second item used in the event.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 device failed during use".No negative impact in state of health reported.
Additional Manufacturer Narrative
We will not further proceed to report this event under this mdr number because it is a duplicate of 9610617-2025-00580.
Additional Manufacturer Narrative
Result of investigation: during the inspection of the devices the error description provided by the customer "failed during use" was confirmed, and further defects were detected.The device met the test specifications 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 fault is wear of the adhesive on the tip of the c-mac blade, which was caused by wear during use and the reconditioning process.The wear of the adhesive allows liquid to penetrate the blade, which affects the electronics and can lead to product failure.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC VIDEO LARYNGOSCOPE MAC #4
• Common Device Name: C-MAC VIDEO LARYNGOSCOPE MAC #4
• 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: 22161262
• Report Number: 9610617-2025-00998
• Device Sequence Number: 18018904
• Product Code: CCW
• UDI-Device Identifier: 04048551389454
• UDI-Public: 04048551389454
• 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): 10/30/2025

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: 8403BXC
• Device Catalogue Number: 8403BXC
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 10/16/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/24/2025; 10/30/2025
• 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