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); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: a visual and functional test was carried out on the endoscope.The error description provided by the customer "white screen reported" was not confirmed, and further defects were detected.1.Image missing.2.Interface board moisture damage.3.Supply cable chemical damage.4.Buttons not functioning.5.Steering mechanism liquid inside.6.Distal head hit marks.7.Distal rubber worn.8.Working shaft kinked.9.Handgrip surface coating exposed.10.Housing surface coating exposed.11.Housing fluid invasion.After connecting the endoscope to the c-mac z8404 zx monitor (sn: (b)(6)), the image was not displayed.Further investigation revealed extensive wear and tear on the endoscope, as well as oxidation of the supply plug pins.Although no leakage was detected during testing, the endoscope was found to contain liquid internally, and multiple components showed severe liquid damage.The investigation determined that liquid had entered the endoscope through the vent valve, allowing moisture to reach and damage the internal electronic components, ultimately resulting in image loss.The cause of the customer reported problem is user induced damage and misuse.The event is filed under internal karl storz complaint id: (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 ; +1(424)218-8247
• MDR Report Key: 50122171
• Report Number: 9610617-2026-01800
• Device Sequence Number: 10560387
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182186
• 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,Followup
• Report Date (Section B): 09/17/2026

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?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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