MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CMOS VIDEO-RHINO-LARYNGOSCOPE, 2.9 MM

Model Number	11102CM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question (11102cm, cmos video rhino-laryngoscope, 2.9 mm, serial number (b)(6), manufactured february 7, 2024) was received by the manufacturing site in germany on february 7, 2026 for investigation.During the technical inspection, the error description provided by the customer "the scope is showing white screen" was not confirmed.A visual and functional test was carried out on the endoscope.The endoscope has normal wear marks on outer surfaces.Image was inspected using c-mac z8404 zx monitor sn (b)(6).Image quality is good.Angle cover has small leak.As stated, all the devices passed the quality check at the time of delivery.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.In addition, the fault could also be due to the endoscope works c-mac monitor to which the cable is connected.To check this, both devices would need to be sent in for inspection.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: "the scope is showing white screen and no image was coming from the scope." no negative impact in state of health reported.
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).

• Brand Name: CMOS VIDEO-RHINO-LARYNGOSCOPE, 2.9 MM
• Common Device Name: CMOS VIDEO-RHINO-LARYNGOSCOPE, 2.9 MM
• 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: 24599927
• Report Number: 9610617-2026-00567
• Device Sequence Number: 8568557
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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
• Report Date (Section B): 04/16/2026

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: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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