MAUDE Adverse Event Report: KARL STORZ ENDOVISION HOPKINS RUBINA 30°, NIR/ICG, Ø 5 MM

Model Number	26046BRA
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that they were doing an emergency lap surgery.They were using adapter from the rigid scope to the fiber optic cable.Those adapters only have two threads on them and the fibert optic cable came undone and fell on the draping for the case and caught fire.They are asking to have these three items (scope, image1s, and cable) evaluated to make sure there are no heat, smoke, or other damaged through them.No negative impact in state of health reported.Product 2 concomitant device filed under internal complaint id (b)(4).Product 3 concomitant device filed under internal complaint id (b)(4).
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).Cross reference interal complaint id (b)(4).Cross reference interal complaint id (b)(4).

• Brand Name: HOPKINS RUBINA 30°, NIR/ICG, Ø 5 MM
• Common Device Name: HOPKINS RUBINA 30°, NIR/ICG, Ø 5 MM
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 24317431
• Report Number: 2020550-2026-00277
• Device Sequence Number: 5572487
• Product Code: OWN
• UDI-Device Identifier: 04048551168899
• UDI-Public: 04048551168899
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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): 02/11/2026
• Report Date (Section F): 02/11/2026

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 Number: 26046BRA
• Device Catalogue Number: 26046BRA
• Device Lot Number: 120648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 495ND LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT; TH121 IMAGE1S 4U RUBINA, OPAL1 NIR/ICG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown