MAUDE Adverse Event Report: KARL STORZ IMAGING CCU, MODULAR, IMAGE1 S CONNECT II, US

Model Number	TC201US
Medical Device Problem Codes	Circuit Failure (1089); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).Cross reference complaint ids: (b)(4).
Event or Problem Description
It was reported that "the system froze up completely during a case yesterday, in which they had to reboot the system".It was confirmed that there was no patient impact or injury and the surgeon was able to complete the procedure.No negative impact in state of health reported.Cross reference mdrs: 2027009-2025-02402.2027009-2025-02403.
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as per se - on our very first day of cases on (b)(6) 2025 we received an error message that states menu temporarily unavailable cycle power.The customer's complaint was verified.The customer's system was verified to produce the "menu temporarily unavailable" error message.The customer returned the following devices which were tested together: tc201us, tc301us, and tc304us.The "menu temporarily unavailable" error message was displayed during two occasions.The mtu message occurs when the tc201us davinci processor stops responding.There is no known component level rework to address the mtu issue, so a tc201us motherboard replacement is required to correct the complaint.The root cause was determined as tc201us has intermittent motherboard causing menu temporarily unavailable message.This event is filed under internal complaint id (b)(4).Cross reference complaint ids: (b)(4).

• Brand Name: CCU, MODULAR, IMAGE1 S CONNECT II, US
• Common Device Name: CCU, MODULAR, IMAGE1 S CONNECT II, US
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 23874032
• Report Number: 2027009-2025-02401
• Device Sequence Number: 14845507
• Product Code: FET
• UDI-Device Identifier: 04048551422625
• UDI-Public: 04048551422625
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K233333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: TC201US
• Device Catalogue Number: TC201US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/10/2026
• 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
• Patient Sex: Unknown