MAUDE Adverse Event Report: KARL STORZ IMAGING ASM,HEAD,IMAGE 1 S, 4U

Model Number	TH120
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, prior to the procedure, the image flickered when the camera head was connected to the camera box.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was shipped to the manufacturing site for investigation.And per their evaluation findings: the complaint issue was described as when the camera head is connected to the camera box, the image flickers, and the surgeon cannot see any image.The customer's complaint was verified.A functional test did not confirm the failure, but contamination was observed on the cable card edge, which is consistent with the customer's complaint.A visual inspection confirmed the contamination.Contamination on the card edge can prevent a proper electrical connection with the ccu.Cleaning the card edge could not completely remove the contamination so a cable replacement is required.The customer should have their ccu inspected for corresponding contamination and wear as the ccu may be the main contributing factor causing the complaint.Additionally, the customer should review their handling and processing methods to ensure that they are following approved karl storz protocols.The cause of the issue was determined as card edge contamination.This event is filed under internal complaint id (b)(4).

• Brand Name: ASM,HEAD,IMAGE 1 S, 4U
• Common Device Name: ASM,HEAD,IMAGE 1 S, 4U
• 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 90245 ; 4242188247
• MDR Report Key: 23538503
• Report Number: 2027009-2025-02077
• Device Sequence Number: 4903236
• Product Code: FET
• UDI-Device Identifier: 04048551370506
• UDI-Public: 04048551370506
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 11/12/2025

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: TH120
• Device Catalogue Number: TH120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 11/12/2025
• 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