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

Model Number	TC201US
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 tc201us was not producing an image.The customer returned the following devices, which were all tested together: tc201us, tc200us and tc301us.The returned tc201us unit had an iml/display port connector that was extremely dusty with debris.This connector was cleaned by blowing out the loose debris with compressed air, and then lightly scrubbed with alcohol and nylon brush.After iml/display port cleaning, the display module was tested and then produced solid images, and cable manipulation was unable to impact the image quality.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 CONNECT II, US
• Common Device Name: CCU, MODULAR, IMAGE1 S CONNECT II, 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: 22666437
• Report Number: 2027009-2025-01322
• Device Sequence Number: 12622493
• Product Code: FET
• UDI-Device Identifier: 04048551422625
• UDI-Public: 04048551422625
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K233333
• 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: TC201US
• Device Catalogue Number: TC201US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• 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