MAUDE Adverse Event Report: KARL STORZ IMAGING CCU,MODULAR,IMAGE1 S X-LINK,US

Model Number	TC301US
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the system froze up completely during a case yesterday, in which they had to reboot the system".It was confirmed that there was no patient impact or injury and the surgeon was able to complete the procedure.No negative impact in state of health reported.Cross reference mdrs: 2027009-2025-02401.2027009-2025-02403.
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).Cross reference complaint ids: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as unit giving an error on first day of cases on (b)(6) 2025.Customer received an error message that states "menu temporarily unavailable cycle power".The same message continues to pop up.The customer's complaint was verified.The customer's system was verified to produce the "menu temporarily unavailable" error message.The customer returned the following devices which were tested together: tc201us (b)(4), tc301us (b)(4), and tc304us (b)(4).During evaluation, on two occasions the "menu temporarily unavailable" error message was displayed to confirm the issue.The "menu temporarily unavailable" message occurs when the tc201us davinci processor stops responding.Additionally, debris was observed around the edac camera receptacle of the tc301us.The edac receptacle should be replaced to ensure proper connection to camera heads.Contamination was observed on the tc304us camera receptacle pins for which the motherboard will be replaced.Units that display the menu temporarily unavailable error message require a tc201us motherboard replacement to resolve the reported issue.The cause of the issue was determined that menu temporarily unavailable error message indicates the davinci processor on the tc201us has stopped responding.Debris observed on tc301us edac connector and contamination on tc304us camera receptacle pins is consistent with intermittent image issues.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint ids: (b)(4).

• Brand Name: CCU,MODULAR,IMAGE1 S X-LINK,US
• Common Device Name: CCU,MODULAR,IMAGE1 S X-LINK,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 90245 ; 4242188247
• MDR Report Key: 23874043
• Report Number: 2027009-2025-02402
• Device Sequence Number: 12142550
• Product Code: FET
• UDI-Device Identifier: 04048551356562
• UDI-Public: 04048551356562
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/10/2026

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: TC301US
• Device Catalogue Number: TC301US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/10/2026
• 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