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

Model Number	TC301US
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to our us facility on (b)(6) 2025, and will later 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)(6).
Event or Problem Description
It was reported that during a procedure (case type was not provided) on (b)(6) 2025, device had intermitting blackouts.They were able to complete the procedure with a back-up unit without any patient impact.
Additional Manufacturer Narrative
Per evaluation from the manufacturer: complaint verified - the camera card edge would not seat properly in the camera receptacle.A functional test confirmed the customer's complaint.The issue was caused because of a missing card edge receptacle roller pin.This roller pin became missing/dislodged because the roller pin retainer lip had broken.A visual inspection confirmed excessive amounts of contamination around the front panel near the broken roller pin receptacle.This contamination likely weakened the retainer lip causing it to break.The customer's receptacle was damaged due to contamination from improper sterilization.The entire receptacle, edac, and front panel will need to be replaced to address the customer's issue.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: 21407222
• Report Number: 2027009-2025-00244
• Device Sequence Number: 15507494
• Product Code: FET
• UDI-Device Identifier: 04048551356562
• UDI-Public: 04048551356562
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/14/2025

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: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/14/2025
• 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