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

Model Number	TC201US
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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 there was no signal.Not communicating with the tc304us.No negative impact in state of health reported.
Event or Problem Description
It was reported that there was no signal.Not communicating with the tc304us.No negative impact in state of health reported.Cross reference mdr: 2027009-2026-00745.
Additional Manufacturer Narrative
Section b5 has been corrected to cross reference mdr 2027009-2026-00745.Device evaluation: the complaint issue was described as not communicating with the tc304us.There is no signal.The customer's complaint was verified.The tc304us did not display an image with th120 or th121 camera heads.The customer returned their tc201us (service order: (b)(4)) & tc304us (service order: (b)(4)), which were tested together.The tc304us was not recognized by the tc201us.This was due to a mismatch in software between the two devices: the tc201us had s/w v4.5 and the tc304us had s/w v4.3.After the tc304us was upgraded to v4.5 the communication issue was corrected.However, at this point, the system displayed an incompatible head message when a camera was inserted, and it would not display an image.Troubleshooting found that the head_present_b signal was unresponsive when a camera head was inserted.This means the ccu was not detecting a camera connection, thus preventing the voltage sequence required for producing an image.A resistance measurement found an open circuit path between the external facing samtec camera receptacle head_present_b pin and the tc304us motherboard components.Ultimately, this motherboard is two years old, and the discontinuity of the head_present_b trace can't be corrected via component level rework, so a motherboard replacement is required.The cause of the issue was isolated to the customer's tc304us: discontinuity of the head_present_b trace between the samtec camera receptacle (pin 5) and the first component on the motherboard (tp13000).The event is filed under internal karl storz complaint id: (b)(4).Cross reference 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 ; GM 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta, ca 93117 ; GM 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24670065
• Report Number: 2027009-2026-00638
• Device Sequence Number: 17407166
• Product Code: FET
• UDI-Device Identifier: 04048551422625
• UDI-Public: 04048551422625
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/02/2026

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: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/02/2026
• 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