MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS RUBINA 30°, NIR/ICG, Ø 10 MM 2

Model Number	26003BRA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast surgery using a karl storz 10 mm laparoscope (model: 26003bra) in conjunction with a tl400 cold light source (with the automatic brightness mode on).An unexpected incident occurred during the operation, resulting in the patient's skin being burned by the lens[?] after the produce, the patient did not require additional intervention treatment and the condition was controllable.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS RUBINA 30°, NIR/ICG, Ø 10 MM 2
• Common Device Name: HOPKINS RUBINA 30°, NIR/ICG, Ø 10 MM 2
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21936322
• Report Number: 2020550-2025-00706
• Device Sequence Number: 5355980
• Product Code: OWN
• UDI-Device Identifier: 04048551436240
• UDI-Public: 04048551436240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/30/2025
• Report Date (Section F): 04/30/2025

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: 26003BRA
• Device Catalogue Number: 26003BRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown