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

Model Number	091330-06
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 091330 not producing an image during a patient examination with lot# 500119208 (091330 flexible rhinolayngoscope).The customer states that they used an new scope from same lot numbers and were able to complete the procedure.The provider was dr.Korner and the patient was not harmed but there was a case delay estimated about 5 minutes.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device will not be forwarded to the manufacturer for further investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id_(b)(4).
Additional Manufacturer Narrative
Correction: mdr was previously filed with the wrong manufacturer number.The correct manufacturer number should have been 9610617.We will continue to use mdr number 1221826-2026-00863 for additional supplementals going forward.Correction in section d-3 and g1.This event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CMOS VIDEO RHINO-LARYNGOSCOPE SSU
• Common Device Name: CMOS VIDEO RHINO-LARYNGOSCOPE SSU
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu MA 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; dr.-karl-storz-strasse 34; tuttlingen, deu, CA 78532 ; GM 78532 ; 4242188247
• MDR Report Key: 24915717
• Report Number: 1221826-2026-00863
• Device Sequence Number: 9085907
• Product Code: EOB
• UDI-Device Identifier: 04048551417331
• UDI-Public: 04048551417331
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 091330-06
• Device Catalogue Number: 091330-06
• Device Lot Number: 500119208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female