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

Model Number	091330-06
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It's been reported: the scope had no light or image.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).

• Brand Name: CMOS VIDEO RHINO-LARYNGOSCOPE SSU
• Common Device Name: CMOS VIDEO RHINO-LARYNGOSCOPE SSU
• Manufacturer (Section D): KARL STORZ SE & CO.KG; dr.karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 23995751
• Report Number: 9610617-2026-00029
• Device Sequence Number: 13317697
• Product Code: EOB
• UDI-Device Identifier: 04048551417331
• UDI-Public: 04048551417331
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K192090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 091330-06
• Device Catalogue Number: 091330-06
• Device Lot Number: 100118530
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown