MAUDE Adverse Event Report: KARL STORZ IMAGING CCU,MODULAR,4U-LINK,US

Model Number	TC304US
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, there was a dropping the signal intermittently.Failed during the case no patient injured.They swapped tc304us and they were able to finish the case.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 dropping signal intermittently and the tension spring is missing.The customer's reported complaint of intermittent image issues was verified.A visual inspection found debris, contamination, and significant wear in the samtec camera connector.All these observed issues are consistent with the intermittent image complaint.The samtec camera connector can't be replaced at ksna goleta, so a motherboard replacement is required to address the customer's issue.The tension spring was missing.There were no issues with the u-shaped bracket that mechanically secures the camera card edge in the ccu receptacle.However, there were several missing spring fingers, and one spring finger was found floating inside the chassis.Considering the contamination and debris observed in the camera receptacle, it's recommended that the customer reviews their handling/processing methods to ensure they are following approved karl storz protocols.Also, the customer should inspect their camera card edge connectors to ensure there isn't any corresponding wear or contamination.The cause of the issue was determined as improper sterilization and maintenance.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CCU,MODULAR,4U-LINK,US
• Common Device Name: CCU,MODULAR,4U-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: 24133919
• Report Number: 2027009-2026-00099
• Device Sequence Number: 21418593
• Product Code: FET
• UDI-Device Identifier: 04048551418123
• UDI-Public: 04048551418123
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 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: TC304US
• Device Catalogue Number: TC304US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 01/21/2026
• 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