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

Model Number	11102CM
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laryngoscope shaft was kinked and leaking, and that it provided no image.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).
Additional Manufacturer Narrative
A visual and functional test was carried out on the endoscope.The endoscope shows signs of wear and scratches.The angle cover shows wear marks.The distal tip is deformed, and the vertebrae links are loose from the rivets because of external force.Endoscope housing shows chemical damage.The working shaft is deformed and twisted near the strain relief, and the working shaft is also leaking from the deformed area.After connecting the endoscope to the c-mac z8404 zx monitor (sn: (b)(6)), the camera head did not display a video image.It was detected that the coating of the imager cable was damaged at the same location where the working shaft was damaged.This caused electrical damage to both the imager and the circuit board.The endoscope did not show any signs of liquid damage.The error described by the customer - "shaft kinked, leaky, no image " - could be confirmed.The cause of the image loss is the damaged imager cable.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: 23089754
• Report Number: 9610617-2025-01647
• Device Sequence Number: 13387428
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/19/2026

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: 09/10/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 03/19/2026
• 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