MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CMOS VIDEO-RHINO-LARYNGOSCOPE, 2.9 MM

Model Number	11102CM
Medical Device Problem Codes	No Display/Image (1183); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to 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 laryngoscope shaft was kinked and that it provided no image.No negative impact in state of health reported.
Additional Manufacturer Narrative
During technical investigation a visual and functional test was carried out and the following was observed: image missing, angle cover is worn, rivets of the vertebrae are broken, distal head is deformed, inserting part is deformed, chemical damage at the housing.After connecting the endoscope to the c-mac z8404 zx monitor (sn: (b)(6), the image could not be displayed on the monitor.Upon further investigation, it was revealed that the rivets of the vertebrae links were broken and the links had become loose.This resulted in increased friction within the vertebrae during articulation of the endoscope.The excessive mechanical resistance caused damage to the imager at the distal tip, which led to a loss of image.The cause of the customer described problem is user-induced mechanical damage to the vertebrae, which led to a loss of image.A manufacturing failure can be excluded.Appropriate warnings about the correct handling of the device and the product testing as well as precautions and warnings are included in the corresponding instructions for use.Internal karl storz reference number: (b)(4).

• Brand Name: CMOS VIDEO-RHINO-LARYNGOSCOPE, 2.9 MM
• Common Device Name: CMOS VIDEO-RHINO-LARYNGOSCOPE, 2.9 MM
• 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: 24016284
• Report Number: 9610617-2026-00036
• Device Sequence Number: 8953044
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K182186
• 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): 05/04/2026

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: 11102CM
• Device Catalogue Number: 11102CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 05/04/2026
• 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