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

Model Number	TC304US
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported: "missing connection pins inside camera port.Discovered when image started flickering during a case.No patient harm.Case was able to be finished." no negative impact 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 missing connection pins inside the camera port and discovered when the image started flickering during a case.The customer's complaint was verified.There were several broken spring fingers in the camera receptacle.A visual inspection confirmed the broken spring finger pins.This will require a camera receptacle replacement.A functional test was unable to identify any issues with image quality or stability.A visual inspection of the camera receptacle observed worn pins and debris.Since the camera receptacle is not replaceable at ksus goleta, a motherboard replacement is highly recommended to ensure a reliable electrical gold-on-gold connection between ccu and camera.The customer's broken ground pins complaint was confirmed and will require a receptacle replacement, but no issues related to image quality or image capture were encountered.Note: the customer should inspect the camera card edge for corresponding wear/damage.The cause of the issue was determined as unable to duplicate the flickering image complaint, but grounding spring fingers pins were damaged due to normal wear and tear.The camera receptacle is worn.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
• 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: 23303141
• Report Number: 2027009-2025-01818
• Device Sequence Number: 14648468
• Product Code: GWG
• UDI-Device Identifier: 04048551418123
• UDI-Public: 04048551418123
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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