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

Model Number	11102CM
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408)
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 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 "it loose the image, during angulation, or suddenly.Stripes in the image sometimes.The videorhinoscope was tested prior to the intervention, and the doctor observed the image problem, during the angulation of the flexible.They have a back-up (single use), to do the procedure.The procedure wasn't delayed." no negative impact in state of health reported.
Additional Manufacturer Narrative
Investigation results: the endoscope concerned (11102cm, serial (b)(6)) was sent to the manufacturer for inspection and a visual and functional test was carried out.The endoscope shows signs of wear and scratches.The angle cover shows wear marks.There is no leakage detected on the endoscope.After connecting the endoscope to a monitor the camera head did not display a video image.The error described by the customer "it loose the image, during angulation, or suddenly.Stripes in the image sometimes." could be confirmed.The endoscope did not show any external or liquid damage.The cause of the problem is concluded to be a failure of a component.In addition, we would like to refer to the following information in the instructions for use (instruction manual flexible cmos video-rhino-laryngoscope - series 11101 cm, 11102 cm, document #: 96056039d, version 3.1 - 01/2020).Page 11: " warning: every time the cmos video-rhino-laryngoscope is used, you must first check that it, and any accessories used in combination with it, is in perfect condition.Damaged cmos video-rhino-laryngoscopes or damaged accessories must not be used." page 26: "10.12 inspecting the image quality.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 cmos video-rhino-laryngoscope from the patient's body gently and carefully.If the cmos video-rhino-laryngoscope 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).
Additional Manufacturer Narrative
Investigation results: the endoscope concerned (11102cm, serial (b)(6)) was sent to the manufacturer for inspection and a visual and functional test was carried out.The endoscope shows signs of wear and scratches.The angle cover shows wear marks.There is no leakage detected on the endoscope.After connecting the endoscope to a monitor the camera head did not display a video image.The error described by the customer "it loose the image, during angulation, or suddenly.Stripes in the image sometimes." could be confirmed.The endoscope did not show any external or liquid damage.The cause of the problem is concluded to be a failure of a component.In addition, we would like to refer to the following information in the instructions for use (instruction manual flexible cmos video-rhino-laryngoscope - series 11101 cm, 11102 cm, document #: (b)(4), version 3.1 - 01/2020).Page 11: " warning: every time the cmos video-rhino-laryngoscope is used, you must first check that it, and any accessories used in combination with it, is in perfect condition.Damaged cmos video-rhino-laryngoscopes or damaged accessories must not be used." page 26: "10.12 inspecting the image quality 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 cmos video-rhino-laryngoscope from the patient's body gently and carefully.If the cmos video-rhino-laryngoscope 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: 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: 23021712
• Report Number: 9610617-2025-01581
• Device Sequence Number: 18519713
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

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: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 02/20/2026; 02/20/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 03/16/2026; 03/18/2026
• 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