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	01/15/2026
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 ids: (b)(4).
Event or Problem Description
It was reported that "complete failure causing delayed surgery.Completely failed, no dashboard, no video signal out of any output".No negative impact in state of health reported.Cross reference mdrs: 2027009-2026-00163, 2027009-2026-00164, 2027009-2026-00165, 2027009-2026-00167, 2027009-2026-00168.
Additional Manufacturer Narrative
Additional information has been received as reflected in sections b1, b5, and h1.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint ids: (b)(4).
Event or Problem Description
It was reported that "complete failure causing delayed surgery.Completely failed, no dashboard, no video signal out of any output".No negative impact in state of health reported.Additional information was received on 11-feb-2026.According to the additional information the procedure was delayed by one hour.Cross reference mdrs: 2027009-2026-00163, 2027009-2026-00164, 2027009-2026-00165, 2027009-2026-00167, 2027009-2026-00168.
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as completely failed, no dashboard and no video signal out of any output.The reason for return was isolated to the two customer's tc201us devices.This tc304us passed multiple overnight burn-in sessions without issue.This included heavy cable manipulation and mechanical shock, yet no image failures were induced.Extensive camera connection/disconnection cycles were performed without any issues.However, even though no functional issues were encountered, concerns were observed with this device.The service incoming tag identified "possible damage due improper packaging".A visual inspection observed that the front panel was separating from the chassis, and loose hardware was heard rattling in the chassis.The loose hardware was a broken nonconductive tab from the front panel that latches to the chassis.This will require a front panel & plate capacitor replacement.The cause of the issue was isolated to the customer's tc201us devices.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint ids: (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: 24202932
• Report Number: 2027009-2026-00166
• Device Sequence Number: 21248248
• Product Code: FET
• UDI-Device Identifier: 04048551418123
• UDI-Public: 04048551418123
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 03/24/2026

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: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 03/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/18/2026; 03/24/2026
• 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
• Patient Sex: Unknown