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

Model Number	11101HD
Medical Device Problem Codes	No Display/Image (1183); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the image went black and there was no light output from the scope during procedure.The scope was withdrawn, after which a new scope had to be introduced.The surgical prolongation was less than 15 minutes.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: a comprehensive visual and functional inspection was carried out on the endoscope.The handgrip and housing were found to be in excellent condition, showing no scratches or signs of wear.The shaft was also in good condition, with no visible damage.Image quality and light output were tested and confirmed to be satisfactory.The inspection was performed using the following equipment: tc200 (sn: (b)(6)), tc304 (sn: (b)(6)), tc300 (sn: (b)(6)), and x-link tc301 (sn: (b)(6)).The issue reported by the customer, "no image," could not be reproduced during testing, and no faults were detected on the endoscope.Based on the investigation, possible causes for the reported problem include a malfunction in another device within the image chain or a defective or incorrectly connected cable.However, the exact cause could not be determined.Given the findings, user error or misuse is considered the most likely reason for the missing image.This event is filed under internal 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: 22912238
• Report Number: 9610617-2025-01485
• Device Sequence Number: 9110980
• Product Code: EOB
• UDI-Device Identifier: 04048551416389
• UDI-Public: 04048551416389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 12/15/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/26/2025; 12/18/2025
• 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