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

Model Number	11102CM
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "the device is not working properly: the light saturates and everything turns white or even black inside the cavity, making it impossible to perform an examination".No negative impact in state of health reported.
Additional Manufacturer Narrative
The initial report for this event was over reported and has already been reported under case (b)(4) mdr 26-188.Therefore, there will be no supplemental reports for 26-210 going forward.Please see mdr 26-188 for future information regarding the evaluation of the product related to this event.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
• MDR Report Key: 24242042
• Report Number: 9610617-2026-00210
• Device Sequence Number: 10188378
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/03/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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