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

Model Number	26606BCA
Medical Device Problem Codes	Break (1069); Material Discolored (1170); No Display/Image (1183); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "the device was installed and put into use in (b)(6) 2025.On (b)(6) 2026, during a surgical procedure, no image was displayed after the scope was connected to the main unit.Inspection revealed a crack at the root of the connecting cable.Verified with cssd: no cracks were found prior to sterilization." no negative impact in state of health reported.It was reported that the surgery was prolonged by 35 minutes.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device was sent to the karl storz assessment and repair department for inspection.During the technical inspection, the reported issue could be confirmed.The following damage/ defects were identified: - cable connector broken - deformation problem, connection pins deformed - the handgrip is discolored - the shaft is scratched.The optical connector on the tipcam has snapped, bending the electrical pins in the process.Based on the damage found, it is concluded that the connector was damaged chemically and/or mechanically, leading to it snapping.The investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.In addition, we would like to call your attention to the following information stated in the instructions for use (document no.: 96286008d, version: v3.2_09-2023).Page 5: "warning: risk of injury: incorrectly assembled and damaged instruments can lead to injuries to the patient.Instruments and all of the accessories used in combination with them must be checked immediately before and after every use to ensure that they are complete, free from damage, and in full working order and have no accidental rough surfaces, sharp corners, burred edges or projecting parts.Care must be taken not to leave missing or broken-off components inside the patient.Warning: risk of injury: overloading the instrument by exerting too much force on it may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original positions." the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D
• Common Device Name: Confocal Optical Imaging
• 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: 24369113
• Report Number: 9610617-2026-00321
• Device Sequence Number: 9471378
• Product Code: OWN
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26606BCA
• Device Catalogue Number: 26606BCA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 09/23/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/09/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown