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

Model Number	8401HX
Medical Device Problem Codes	Use of Device Problem (1670); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to manufacturer on may 12, 2025.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
According to the information received, the customer has reported image goes dark when in use.Also, the cover glass at the distal window looks to be missing.No negative impact in state of health reported.
Additional Manufacturer Narrative
During the manufacturer's technical inspection, the error description provided by the customer "the small transparent lens cover (approximately 1mm) of the blade was found missing after use was conformed and further defects were detected.In total the following defects were detected: blade damaged blade bent adhesive joints on camera head worn missing flat glass connecting piece worn plug oxidized plug worn handle deformed leaking product labelling worn as mentioned above, 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.For this reason, a user misuse error is to be assumed which led to the missing glass.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints, no trend was identified.The labelling was found to contain adequate instructions and warnings.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: 22080377
• Report Number: 9610617-2025-00914
• Device Sequence Number: 18318556
• Product Code: CCW
• UDI-Device Identifier: 04048551251935
• UDI-Public: 04048551251935
• 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): 05/06/2026

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
• Device Lot Number: 13235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 05/06/2026
• 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