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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "no image, new unit, no humidity inside".No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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 inspection of the returned product, the following was found: a visual and functional test was carried out on the endoscope.The error described by the customer "no image" could be confirmed.The cause of this fault is a damaged image sensor cable.The corresponding ifu 96056041d, version v1.1_10-2020 contains the following note (page 9, 12 and18): warning: risk of injury: whenever the flexible videoscope is used, you must first check that it, and any accessories used in combination with it, are in perfect condition.Warning: risk of injury: if the flexible videoscope malfunctions during use on the patient, discontinue use immediately.> place the distal tip of the flexible videoscope in the neutral, non-deflected position and remove the flexible videoscope slowly and carefully from the patient.Warning: if the image fails or there is interference during use in the patient, put the distal tip into the neutral position and remove the device from the patient's body gently and carefully.If the videoscope is used in the patient after the image has failed or when there is interference, this may result in serious injury to the patient.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: 21515604
• Report Number: 9610617-2025-00359
• Device Sequence Number: 7901837
• Product Code: EOB
• UDI-Device Identifier: 04048551416389
• UDI-Public: 04048551416389
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/03/2025

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
• Device Lot Number: 70856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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