MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HD VIDEO-RHINO-LARYNGOSCOPE, 3.7MM

Model Number	11101HD
Medical Device Problem Codes	Circuit Failure (1089); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the 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 device does not shows image.No negative impact in state of health reported.
Additional Manufacturer Narrative
Accordingly, we would like to give a summary of our results regarding the reported issue.A visual and functional test was carried out on the endoscope.The endoscope shows slight wear marks.No light and no image output.Moisture that had penetrated the device damaged the interface board, which in turn affected the endoscope's electronics, leading to loss of image and light.Since the endoscope was tight, moisture could only have entered the endoscope through the pressure equalization valve.For this reason, it is reasonable to concluded that an operator error led to the failure of the image display.In addition, we would like to call your attention to the corresponding instructions for use (document#: (b)(4), version v1.1_10-2020) on page 23 and 24 chapter 7.5.2 performing the leakage test - in liquid."remove the endoscope from the liquid and press the vent button on the manometer.The test pressure must drop to 0 before the leakage tester can be removed.Note: never release the pressure in the liquid." and in chapter 7.7.1 manual cleaning on page 24 and 25."attention: the pressure compensation cap must not be in place on the vent port for cleaning and disinfection." the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HD VIDEO-RHINO-LARYNGOSCOPE, 3.7MM
• Common Device Name: HD VIDEO-RHINO-LARYNGOSCOPE, 3.7MM
• 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: 24306344
• Report Number: 9610617-2026-00275
• Device Sequence Number: 9660905
• Product Code: EOB
• UDI-Device Identifier: 04048551416389
• UDI-Public: 04048551416389
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K200740
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 11101HD
• Device Catalogue Number: 11101HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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