MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D

Model Number	26606BCA
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that image is blurry.No negative impact in state of health reported.The risk is covered in the related risk file (sap-id: (b)(4), version: bf; risk id: (b)(4); severity-level: 3 (tissue trauma, reversible, associated with significant prolongation of the procedure / duration of anesthesia).

• Brand Name: TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D
• Common Device Name: TIPCAM1 RUBINA 30°, 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: 24231047
• Report Number: 2020550-2026-00183
• Device Sequence Number: 10175302
• Product Code: GCJ
• UDI-Device Identifier: 04048551425688
• UDI-Public: 04048551425688
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 02/01/2026
• Report Date (Section F): 02/01/2026

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: 26606BCA
• Device Catalogue Number: 26606BCA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• 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