MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1S 4U RUBINA, OPAL1 NIR/ICG

Model Number	TH121
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the camera had a hazy image and halo effect around the image.After switching cameras there was improvement but due to bleeding and some continued visualization issues the case had to be cancelled.Cross reference mdr: 2027009-2025-01230.
Additional Manufacturer Narrative
Customer will not return the devices to the manufacturing site 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).Cross reference complaint id: (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site.No equipment was returned to karl storz goleta for the complaint investigation, so the complaint can't be verified or confirmed.Since the customer's camera was not returned, the image it produced could not be directly compared to a known working th121.Without this comparison there is no way to know if the customer's camera is functioning properly.The following are some possible explanations for a hazy image: ---broken endoscope.---dirty endoscope.---dirty lenses in the optical assembly - could be the external to the front lens window of contamination on the internal lenses.---internal moisture in the camera.---camera not properly focused.---light source settings issues.---internal debris/contamination on the camera sensor.---dirty/worn ccu connector or camera card edge.---internal ccu component issue.---internal camera component issue.---monitor settings issue.---ccu/monitor cable issue.Without any of the customer's equipment to evaluate, no conclusions can be made.Unable to determine cause since the customer's equipment was not returned for evaluation.This event is filed under internal complaint id (b)(4).Cross reference complaint id: (b)(4).

• Brand Name: IMAGE1S 4U RUBINA, OPAL1 NIR/ICG
• Common Device Name: IMAGE1S 4U RUBINA, OPAL1 NIR/ICG
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22546402
• Report Number: 2027009-2025-01229
• Device Sequence Number: 20986405
• Product Code: OWN
• UDI-Device Identifier: 04048551430569
• UDI-Public: 04048551430569
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201399
• 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): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TH121
• Device Catalogue Number: TH121
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 68 KG