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

Model Number	TC301US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the customer's complaint was verified.The customer's tc301us was not producing an image when a camera was connected.The customer returned the following devices, which were all tested together: tc201us, tc200us and tc301us.The tc301us ccu had corroded/contaminated edac connector consistent with the customer's no image complaint.The tc301us ccu will need edac replacement to ensure a reliable connection with the customer's camera.The customer's black/blank screen complaint when cameras were connected was caused by contamination/corrosion in the edac camera connector, which will need to be replaced.It is highly recommended that the customer reviews their handling/processing methods to ensure they are following approved karl storz protocols.The cause of the issue was determined as improper sterilization/cleaning by the customer.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "units are going black/blank when a camera is plugged in.Cut out in middle of procedure".No negative impact in state of health reported.

• 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
• MDR Report Key: 22666433
• Report Number: 2027009-2025-01319
• Device Sequence Number: 12622492
• Product Code: FET
• UDI-Device Identifier: 04048551356562
• UDI-Public: 04048551356562
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 07/30/2025

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: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/30/2025
• 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