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); 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
The following was reported: light but no image.There is no information that the event caused a harm or serious injury to patient, user or third party.
Additional Manufacturer Narrative
Device evaluation: during investigation of the returned device the following was detected.A visual and functional test was carried out on the endoscope.The surface of the handgrip and housing shows signs of a chemical damage.The endoscope shows no image, no light output and no button function.Upon further review, the root cause of all three of the above-mentioned failures was damage to the gold fingers (card edge) on the ccu cable plug.There are many connections at the base that are not complete causing the failures, missing image and light.These defects are attributable to insufficient maintenance and care.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
• MDR Report Key: 23085973
• Report Number: 9610617-2025-01637
• Device Sequence Number: 18567471
• Product Code: EOB
• UDI-Device Identifier: 04048551416389
• UDI-Public: 04048551416389
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 11/26/2025

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
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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