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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS RUBINA 30, NIR/ICG, 0 10 MM
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KARL STORZ SE & CO. KG HOPKINS RUBINA 30, NIR/ICG, 0 10 MM Back to Search Results
Model Number 26003BRA
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/20/2025
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
According to the information received from the first moment it has suffered fogging, but the situation got worse in surgery.During surgery they lost total vision.The surgery was scheduled for laparoscopy, but they were not able to see anything through optics, in the end they had to change the method of intervention to open surgery.
 
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Brand Name
HOPKINS RUBINA 30, NIR/ICG, 0 10 MM
Common Device Name
HOPKINS RUBINA 30, NIR/ICG, 0 10 MM
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key22211041
Report Number2020550-2025-01003
Device Sequence Number15519370
Product Code OWN
UDI-Device Identifier04048551436240
UDI-Public04048551436240
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) 06/16/2025
Report Date (Section F) 06/10/2025
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 Number26003BRA
Device Catalogue Number26003BRA
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 Manufacturer06/10/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/16/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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