MAUDE Adverse Event Report: KARL STORZ IMAGING CCU,MODULAR,H3-LINK,US

Model Number	TC300US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, loose pins, image cutting out.No death or (unanticipated) serious deterioration in state of health reported.
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).
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as loose pins and image cutting out.The customer's complaint was verified.Intermittent image while connecting test head into edac connector receptacle and intermittent noise across screen once awhile during bounce test.The tc300us was tested with tc201 test unit and test head and produced image but loose image observed during tapping test head connector while connected to edac connector receptacle.Also, intermittent noise across screen once awhile during bounce test.So, edac connector receptacle has possible defective contact connection and the circuit board has possible short or open circuit including possible components failure.Edac connector pins were verified not lose or damaged.Intermittent noise across screen once awhile during bounce test possible caused by short or open circuit board and component failures.The cause of the issue was determined as intermittent possibly caused by the edac connector, short or open circuit and component failures of the circuit board.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CCU,MODULAR,H3-LINK,US
• Common Device Name: CCU,MODULAR,H3-LINK,US
• 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: 24390443
• Report Number: 2027009-2026-00338
• Device Sequence Number: 18797203
• Product Code: FET
• UDI-Device Identifier: 04048551356517
• UDI-Public: 04048551356517
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K131953
• 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): 03/25/2026

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: TC300US
• Device Catalogue Number: TC300US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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