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

Model Number	11101HD
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that picture went purple and switch itself off mid consultation.Procedure was completed successfully.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
Result of investigation: during the technical investigation of the returned product, the following was found: - the shaft is bent approx.325mm from the distal end.- the shaft is squeezed approx.230mm from the distal end.- the cover of the shaft has detached from the substructure.- the adhesive connection between the articulation cover and the distal head has come loose and is leaking.- the vertebrae are corroded.- the endoscope is not recognized by the camera unit and does not generate an image.- the contacts of the supply plug are corroded.- the sheathing of the supply cable shows whitish discoloration.- the housing has impact marks.- the labelling on the control panel is faded.A problem with the image could be confirmed as complained by the customer.Possible causes for the image error can be: the corroded contacts of the supply plug which impair the transmission of the image.A defective sensor that has been damaged by moisture that has penetrated through the leaking angle cover.The electronics in the handle (interface board) may be damaged by vibration (impact marks on the housing).Which of these damages ultimately led to the image defect cannot be determined by the investigation.However, all the damage found during the inspection can be attributed to wear and tear and customer fault.For this reason, a user misuse error is to be assumed which led to the missing image.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: 22439550
• Report Number: 9610617-2025-01155
• Device Sequence Number: 20001015
• Product Code: EOB
• UDI-Device Identifier: 04048551416389
• UDI-Public: 04048551416389
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 09/08/2025

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: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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