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)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
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).Cross reference complaint ids: (b)(4).
Event or Problem Description
It was reported that "complete failure causing delayed surgery.Completely failed, no dashboard, no video signal out of any output".No negative impact in state of health reported.Cross reference mdrs: 2027009-2026-00163, 2027009-2026-00165, 2027009-2026-00166, 2027009-2026-00167, 2027009-2026-00168.
Event or Problem Description
It was reported that "complete failure causing delayed surgery.Completely failed, no dashboard, no video signal out of any output".No negative impact in state of health reported.Additional information was received on 11-feb-2026.According to the additional information the procedure was delayed by one hour.Cross reference mdrs: 2027009-2026-00163, 2027009-2026-00164, 2027009-2026-00166, 2027009-2026-00167, 2027009-2026-00168.
Additional Manufacturer Narrative
Additional information has been received as reflected in sections b1, b5, and h1.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint ids: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as completely failed, no dashboard and no video signal out of any output.The customer's reported complaint was not verified with this device.The camera receptacle roller pins were found to be dislodged, and the edac was in extremely poor condition.A functional test found that this tc300us would power up and display an image.However, a visual inspection observed the following: 1) both receptacle roller pins were dislodged due to broken retainer lips.There was also contamination on the spring finger assembly adjacent to the roller pin retainer lip.2) the edac connector had significant debris throughout.The dislodged roller pins will require a camera receptacle replacement.Furthermore, the condition of the edac will require an edac replacement.It is recommended that the customer reviews their handling/processing methods to ensure they are following approved karl storz protocols.The receptacle roller pin retainer lips likely broke due to brittleness caused by exposure to improper sterilization.The cause of the issue was determined as unable to verify the customer's reported complaint.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint ids: (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: 24202929
• Report Number: 2027009-2026-00164
• Device Sequence Number: 21248247
• Product Code: FET
• UDI-Device Identifier: 04048551356517
• UDI-Public: 04048551356517
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 03/24/2026

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: TC300US
• Device Catalogue Number: TC300US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 03/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/18/2026; 03/24/2026
• 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