MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CMOS VIDEO RHINO-LARYNGOSCOPE

Model Number	11102CM
Medical Device Problem Codes	No Display/Image (1183); Detachment of Device or Device Component (2907)
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 there is a leak and no image.Defect was detected during check up.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the following damages were found during visual and functional investigation: ---image is missing.---liquid damage was found on the interface board.---strain relief of the supply cable is damaged.---buttons are not functioning.---rattling or scraping noises in the steering mechanism.---angle cover leaks due to a cut.---inserting part is kinked.---liquid inside the housing.A visual and functional test was carried out on the endoscope.The endoscope shows signs of wear and scratches.The strain relief of the supply cable shows damage.The steering mechanism rattles and scrapes.The angle cover is mechanically damaged, causing the endoscope to leak.There is moisture in the housing.The sensor and the interface board are damaged by moisture.This also caused the buttons to malfunction.This was caused by a mechanical impact that compressed and damaged the angle cover, causing it to leak.The ingress of moisture caused the sensor and the interface board to fail.For this reason, a user misuse error is to be assumed which led to the missing image.The device passed the quality check at the time of delivery.This event is filed under internal complaint id (b)(4).

• Brand Name: CMOS VIDEO RHINO-LARYNGOSCOPE
• Common Device Name: CMOS VIDEO RHINO-LARYNGOSCOPE
• 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: 22785121
• Report Number: 9610617-2025-01404
• Device Sequence Number: 9822963
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K182186
• 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): 11/18/2025

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: 11102CM
• Device Catalogue Number: 11102CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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