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

Model Number	TC304US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, metal bracket is loose/not holding scope.Procedure delay around 30 minutes.No injury to patient 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 "metal bracket is loose and is not holding scope".The customer's complaint was not verified.No mechanical or functional issues with the tc304us camera receptacle were observed during the complaint investigation.A functional test found that the metal roller pins and u-shaped bracket inside the camera receptacle functioned as designed: the u-shaped tension mechanism mechanically latched on to the camera card edge and released as expected.The front panel was removed, and the receptacle was disassembled and visibly verified to be intact and complete.However, a visual inspection of the ccu camera receptacle observed the following: fibers in the receptacle and contamination on the gold finger camera contacts.The contamination and fibers are consistent with other complaints reporting intermittent and or no image.The receptacle contacts should no longer be used so a motherboard replacement is needed.The root cause pertaining a loose metal bracket could not be determined as it was confirmed the camera receptacle functioned as intended.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: 24005302
• Report Number: 2027009-2026-00037
• Device Sequence Number: 21183670
• Product Code: FET
• UDI-Device Identifier: 04048551418123
• UDI-Public: 04048551418123
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 02/23/2026

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: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/23/2026
• 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