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

Model Number	TC304US
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Serious Injury
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 internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).
Event or Problem Description
It was reported that will not produce any image or dashboard.The issue caused a delay of the procedure.The prolongation was longer than 60 minutes.No negative impact in state of health reported.Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation findings by the manufacturing site: the complaint issue was described as "no image or dashboard".The customer's complaint was verified.The customer returned 4 units for the same no image complaint 2x tc201us (serial numbers: (b)(6)).2x tc304us (service orders: nq800656-p & zr797582-p).A functional test confirmed the customer's complaint was attributed to their tc201us camera control units (ccus).Both tc201us units failed to boot up to the gui: the screen was blank and fans were at full speed.The tc201us top covers were removed, and the following was observed on both devices: the fpga leds were off and so was the max_config_donen led.This indicates that the cpld was unsuccessful in loading the fpga configuration files.Ultimately, both customer's tc201us motherboards will need to be replaced to address the bootup issue.No functional issues were encountered with either tc304us ccu.This event is filed under internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 24203158
• Report Number: 2027009-2026-00155
• Device Sequence Number: 9544085
• Product Code: FET
• UDI-Device Identifier: 04048551418123
• UDI-Public: 04048551418123
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160044
• 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): 02/24/2026

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: TC304US
• Device Catalogue Number: TC304US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/24/2026
• 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: Required Intervention
• Patient Sex: Unknown