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

Model Number	TC301US
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is not yet completed.The investigation results are pending.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that before the start of procedure (case date and type was not provided) the device had no image come up.No negative impact in state of health reported.No patient injury was reported.The surgeon was able to complete the procedure in a different room.
Additional Manufacturer Narrative
Per evaluation from the manufacturer: complaint verified - the tc301us would not boot up.A functional test confirmed the customer's complaint.A visual inspection was unable to detect any obvious issues.Troubleshooting isolated a short between p3v3b and ground, which prevented the device from powering up.Several components were removed to isolate the short and the failed component was identified as u18.The u18 failed preventing the motherboard from powering up properly, and a motherboard replacement is required.This event is filed under internal complaint id (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: 21745278
• Report Number: 2027009-2025-00540
• Device Sequence Number: 18514589
• Product Code: FET
• UDI-Device Identifier: 04048551356562
• UDI-Public: 4048551356562
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/15/2025

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: TC301US
• Device Catalogue Number: TC301US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/15/2025
• 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