MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE

Model Number	TC201
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); No Apparent Adverse Event (3189)
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.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
It was reported that the camera presented a shaking image and sometime a black screen.The shaking is not permanent.It occured few times the sound of the units are very acute and is suggesting a fan problem.This situation occured during use and during a test in our technical department.The procedure was completed successfully with no surgical delay or prolongation of surgery.No negative impact in state of health reported.Cross reference: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the manufacturer's technical inspection of the returned devices, the error description provided by the customer, "shaking image /black screen sometimes" could not be confirmed.Even though the 3 associated units, tc201, tc304 and th120 were tested in the system in continuous operation over several days, the described failure of the customer could not be detected/ determined.The most probable root cause therefore is the cabling on site which may have a loose or not correct connected connection.This event is filed under internal complaint id (b)(4).

• Brand Name: CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE
• Common Device Name: CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22589469
• Report Number: 9610617-2025-01290
• Device Sequence Number: 9128588
• Product Code: FET
• UDI-Device Identifier: 04048551370506
• UDI-Public: 04048551370506
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: TC201
• Device Catalogue Number: TC201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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