MAUDE Adverse Event Report: KARL STORZ IMAGING TC201US

Model Number	TC201US
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 to the 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 information received, it was flickering when connected to the camera.No patient involvement was reported.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as flickering when connected to the camera.The customer's complaint was not verified.No flickering images were detected over multiple days of testing.Functional tests were performed with head module ccus and camera head test fixtures, but no flickering problems were encountered with this tc201us.Testing included multiple overnight burn-in sessions, extensive power cycles, significant mechanical shock, and heavily cable manipulation, but the image never dropped out or flickered.All inputs and outputs were tested.During testing, the customer's tc201us intermittently displayed the "menu temporarily unavailable" error message, which indicates that the davinci processor has stopped responding.Currently, there is no component level rework to be performed at ksna-goleta for the mtu issue, so a motherboard replacement will be required.If the customer is still experiencing the flickering issue, then it is recommended that they return their complete system, so a full evaluation can be performed on all their devices.The cause of the issue was determined as unable to verify the customer's reported complaint, but the "menu temporarily unavailable[?]" error message was encountered and therefore, a motherboard replacement is needed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TC201US
• Common Device Name: TC201US
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta, ca 93117 ; GM 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta, ca 93117 ; GM 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23853634
• Report Number: 2027009-2025-02384
• Device Sequence Number: 9571809
• Product Code: GWG
• UDI-Device Identifier: 04048551422625
• UDI-Public: 04048551422625
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 03/13/2026

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: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/13/2026
• 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