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

Model Number	TC201US
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
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).Cross reference complaint id: (b)(4).
Event or Problem Description
According to the information received the tc304 would not recognize camara and when it did the screen was gray/green.Customer is not sure if the issue is with the tc304 or tc201.No death or (unanticipated) serious deterioration in state of health reported.Additional information received: the procedure was delayed by over 30 minutes.Cross reference mdr: 2027009-2026-00784.
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as the tc304 would not recognize the camera and when it did the screen was gray/green.Customer is not sure if the issue is with the tc304 or tc201 since the tc201 did not send the image to the monitor.The customer's reported complaint of gray/green screen wasn't encountered, but a purple screen was observed during testing.The customer's tc304us and tc201us were tested together.Only on two occasions was a malfunction observed over several weeks of testing.This malfunction was a purple screen.This issue was corrected by only cycling power on the tc304us.This suggests an intermittent failure with the customer's tc304us motherboard.The tc304us motherboard needs to be replaced to prevent future failures.No issues were observed with the customer's tc201us.The failure couldn't be recreated therefore an exact root cause couldn't be determined.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: 24835201
• Report Number: 2027009-2026-00785
• Device Sequence Number: 9187783
• Product Code: FET
• UDI-Device Identifier: 04048551422625
• UDI-Public: 04048551422625
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/15/2026

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: TC201US
• Device Catalogue Number: TC201US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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