MAUDE Adverse Event Report: KARL STORZ SE & Co. KG TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D

Model Number	26606ACA
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the staff member wore two pairs of gloves throughout the procedure.Thirty minutes after the procedure, she experienced pain.They discovered a burn covering the entire surface of the left hand that was in contact with the device.

• Brand Name: TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D
• Common Device Name: TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 50941329
• Report Number: 2020550-2026-01368
• Device Sequence Number: 10749555
• Product Code: OWN
• UDI-Device Identifier: 04048551425671
• UDI-Public: 04048551425671
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 26606ACA
• Device Catalogue Number: 26606ACA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• 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