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

Model Number	TC201US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: complaint verified - intermittently the image would drop out.A functional test confirmed the failure.Troubleshooting found that the dp2 connector was intermittent; moving the dp cable could induce the image drop failure.A visual inspection of dp2 connector found that the alignment mechanism was slightly deformed.The dp2 connector can't be replaced at ksus-goleta so a motherboard replacement will be required.The cause of the issue was determined as deformed cable alignment mechanism on the dp2 output connector.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: "during a case 30 - 45 minutes into the case, the image intermittently goes in and out.Sometimes as long as 10 seconds.Trouble shooting performed by changing cables and changing secondary monitors and the camera.Still experienced the same issue" no negative impact in state of health reported.

• 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
• MDR Report Key: 22732633
• Report Number: 2027009-2025-01378
• Device Sequence Number: 13024392
• Product Code: GWG
• UDI-Device Identifier: 04048551422625
• UDI-Public: 04048551422625
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/06/2025

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: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/06/2025
• 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