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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG POWER LED RUBINA, OPAL1 NIR/ICG
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KARL STORZ SE & CO. KG POWER LED RUBINA, OPAL1 NIR/ICG Back to Search Results
Model Number TL400
Medical Device Problem Code Poor Quality Image (1408)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/08/2026
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
Event or Problem Description
It was reported that during a robotic laparoscopic ventral hernia repair procedure, the resolution and color of the visualization was appearing red.The surgeon converted to laparoscopy because the image turned red when operating near the abdominal wall.According to the available information, the patient suffered a non-serious injury.
 
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Brand Name
POWER LED RUBINA, OPAL1 NIR/ICG
Common Device Name
POWER LED RUBINA, OPAL1 NIR/ICG
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key24302621
Report Number2020550-2026-00212
Device Sequence Number5228200
Product Code OWN
UDI-Device Identifier04048551425695
UDI-Public04048551425695
Combination Product (Y/N)N
Initial Reporter CountrySP
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/05/2026
Report Date (Section F) 02/05/2026
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 NumberTL400
Device Catalogue NumberTL400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer02/05/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/10/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient SexUnknown
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