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

Model Number	26003BRA
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent a breast surgery using a karl storz 10mm 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
Result of investigation: according to customer information, a patient suffered burns to the skin in the chest area due to contact with the distal end of the optic 26003bra mentioned in this report.The optic 26003bra and the tl400 light source used were not returned to us for detailed examination with the explanation "there is no problem with the product, the product can be used." according to customer information, there is no product defect.We would like to call your attention to a warning in the corresponding instructions for use 96216001d_v4.0_11-2017, under point 2.2 safety instructions, 3.6 connecting to the camera system and light source, as well as in the ifu for the tl400 light source ifu 96286010d version 1.3 - 07/2021 on page 7 safety instructions warnings and cautions, page 14 installation and operating instructions point 6.3.5 connecting light cable.Based on the customer's description, we assume that a user error led to the patient's skin being burned.The event is filed under internal karl storz complaint id: (b)(40.

• Brand Name: HOPKINS RUBINA 30°, NIR/ICG, Ø 10 MM
• Common Device Name: HOPKINS RUBINA 30°, NIR/ICG, Ø 10 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21930564
• Report Number: 9610617-2025-00706
• Device Sequence Number: 9096312
• Product Code: OWN
• UDI-Device Identifier: 04048551436240
• UDI-Public: 04048551436240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TL400,POWER LED RUBINA, OPAL1 NIR/ICG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown