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	08/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will 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)(4).Cross reference complaint id: (b)(4).
Event or Problem Description
It was reported that prior to the procedure on (b)(6) 2025 there was a very bad signal and image disruption when using with single scopes.No negative impact in state of health reported.Cross reference mdr: 2027009-2025-00163.2027009-2025-00179.
Additional Manufacturer Narrative
The device was returned to the manufacturing site.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).
Additional Manufacturer Narrative
Per evalution by the manufacturing site: complaint verified - on a few occasions, after several hours of use, the ccu would display incompatible camera head detected, but the image would remain live and usable - no actual image drops were detected during testing.The customer returned 3 devices, which were all evaluated together: tc201us, tc301us, and tc028.The customer did not return any of their single-use scopes, so a test fixture single-use scope was used.During a week and a half of testing, the image never dropped out or was unusable.The incompatible head message only occurred on 3 occasions during a week and a half of testing.Since the failure rate was so low, a specific root cause could not be determined - repeatability was extremely rare and unpredictable.A functional testing indicated that the failure is being caused by the customer's tc301us.This was done by testing the customer's ccu with other test fixture ccus; the failure only occurred on system setup combinations utilizing the customer's tc301us.The issue is related to the customer's intermittent tc301us motherboard, which should be replaced.The issue was isolated to the customer's tc301us.This event is filed under internal complaint id (b)(4).Cross reference complaint id are documented in section h10.

• 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: 21361233
• Report Number: 2027009-2025-00178
• Device Sequence Number: 8438312
• Product Code: FET
• UDI-Device Identifier: 04048551356562
• UDI-Public: 04048551356562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/17/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/13/2025; 03/11/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 02/20/2025; 03/17/2025
• 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