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

Model Number	8403BXC
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cover glass is missing.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation on may 9,2025.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
Result of investigation: during technical inspection of the returned device the following defects were detected: · customer complaint noted · blade damaged · adhesive joints on camera head worn · leaking · housing damaged · cover damaged · plug damaged · software version is up to date · processing at temperatures above device specification (temperature indicator has responded), therefore the electronics and all bonded components must be replaced all production-related quality tests were passed, and no non-conformities were found in the manufacturing records of the devices.The device passed quality control at the time of delivery.Based on the defects identified during the technical inspection, it is concluded that the cause of the described defect is the wear of the adhesive at the tip of the c-mac blade, which was caused by the reprocessing because the temperatures were above the device specification (temperature indicator activated).The wear of the adhesive caused the flat glass to fall out.For this reason, it can be assumed that an operating error led to wear and tear on the adhesive and thus to the failure of the cover glass.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
• 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: 22004535
• Report Number: 9610617-2025-00823
• Device Sequence Number: 9390600
• 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): 10/27/2025

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
• 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: 05/09/2025; 10/21/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 05/14/2025; 10/27/2025
• 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