MAUDE Adverse Event Report: KARL STORZ IMAGING CCU,MODULAR,4U-LINK,US

Model Number	TC304US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, units are not displaying an image.No death or (unanticipated) serious deterioration in state of health reported.
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).
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as both units are not displaying an image.The customer's complaint was verified.The camera receptacles are damaged.The customer returned 2x tc304us (service order: (b)(4)) for the same reason for return.A visual inspection confirmed damage to the samtec connectors on both tc304us.The damage observed was broken/bent gold receptacle contacts consistent with image reliability complaints.Unfortunately, the tc304us camera receptacle can't be replaced at ksna goleta, so the motherboards will have to be replaced on both tc304us ccus listed above.It's recommended that the customer inspects their camera head connectors for corresponding damage.The cause of the issue was determined as damaged samtec camera receptacle.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CCU,MODULAR,4U-LINK,US
• Common Device Name: CCU,MODULAR,4U-LINK,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: 24390445
• Report Number: 2027009-2026-00339
• Device Sequence Number: 21488410
• Product Code: FET
• UDI-Device Identifier: 04048551418123
• UDI-Public: 04048551418123
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/25/2026

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: TC304US
• Device Catalogue Number: TC304US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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