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

Model Number	TC301US
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
The device in question was returned manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the event description "when flex xc1 was plugged in, after about 15 minutes the scope image began to glitch and then went back to blue dashboard then back to scope image glitching again!" there is no information that the event caused a harm or serious injury to patient, user or third party.
Additional Manufacturer Narrative
Device evaluation: customer's complaint was not verified.Unable to duplicate reported issue regarding scope began to glitch after 15 minutes.The device was tested with th110 camera, didn't have tc028 to try and replicate customer's set up.Would suggest sending both units' together if problem persists.Additionally, there was a cooling fan failure causing loud noise which will require a replacement.The device passed all functional tests including burn in test.The cause of the issue was unable to duplicate the customer's reported complaint.The event is filed under internal karl storz 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
• MDR Report Key: 22472957
• Report Number: 2027009-2025-01207
• Device Sequence Number: 4106820
• 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
• Report Date (Section B): 10/16/2025

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: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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