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

Model Number	TC200US
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer will not return the device 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 id: (b)(4).
Event or Problem Description
It was reported that during a sinus diagnostic endoscopy procedure (case date unknown), image on the monitor and smartscreen flickered.They were able to complete the procedure without any patient impact.Cross reference mdr: 2027009-2025-00796.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: there was no problem with the device.A different device of customer's was determined to be the cause of the issue (flickering).This event is filed under internal complaint id: (b)(4).Cross reference complaint id: (b)(4).

• Brand Name: CCU,MODULAR,IMAGE1 CONNECT,US
• Common Device Name: CCU,MODULAR,IMAGE1 CONNECT,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: 22012524
• Report Number: 2027009-2025-00795
• Device Sequence Number: 5228274
• Product Code: FET
• UDI-Device Identifier: 04048551356586
• UDI-Public: 04048551356586
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/27/2025

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: TC200US
• Device Catalogue Number: TC200US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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