MAUDE Adverse Event Report: KARL STORZ ENDO 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	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for 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).
Event or Problem Description
It was reported the scope had no video and no light on 3 scopes and 1 image was distorted and light cut out.It was stated that no patient was affected.No negative impact in state of health reported.
Additional Manufacturer Narrative
The customer will not return the device for evaluation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.
Additional Manufacturer Narrative
Correction in section c was accidently left blank in the initial mdr and now checked no.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Corrections have been made in section b3 - date of event was 03/14/2025, b4 - mdr submission date 04/28/20205 was incorrect on initial mdr it was submitted to fda on 04/30/2025.G3 - awareness date is 04/11/2025.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Previously mentioned cross reference mdrs in section b5 and complaint id in section h11 was in error.No cross reference needed for this complaint.This event is filed under internal complaint id: (b)(4).
Additional Manufacturer Narrative
The device was not sent to the manufacturer for inspection.As there are several components (camera, flex print, pcb, cable, connector, etc.) in the signal chain, which could all cause the described image distortion and light loss, a final determination of the root cause is not possible.This might have a production reason, or it has a handling reason at the user, or a problem in the further signal chain.The above investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.This event is filed under internal complaint id_(b)(4).

• Brand Name: CMOS VIDEO RHINO-LARYNGOSCOPE SSU
• Common Device Name: CMOS VIDEO RHINO-LARYNGOSCOPE SSU
• Manufacturer (Section D): KARL STORZ ENDO; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21918202
• Report Number: 9610617-2025-00700
• Device Sequence Number: 9022024
• Product Code: EOB
• UDI-Device Identifier: 04048551417331
• UDI-Public: 04048551417331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/11/2026

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: 500109335
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 04/16/2025; Not provided; 04/11/2025; 05/19/2025; 01/27/2026
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 04/29/2025; 04/30/2025; 05/01/2025; 05/21/2025; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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