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

Model Number	TH120
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure (type not provided), the image went black and the white balance was incomplete.No harm to patient, user or third occurred.The procedure was completed with a back up device with a delay of 10 minutes.
Additional Manufacturer Narrative
The investigation is not yet completed, investigation results are pending.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Correction is provided in section g2.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per evaluation from the manufacturer: customer's complaint was not verified.The device passed all functional test.The initial evaluation was performed on april 07, 2025.A customer's request to reevaluate the device was performed on (b)(6) 2025; the complaint could not be duplicated and passed all functional test.A request was made by ksus project manager, technical services to remove and replace the camera cable.Unable to duplicate the customer's reported complaint.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: 21942953
• Report Number: 2027009-2025-00748
• Device Sequence Number: 8547830
• Product Code: FET
• UDI-Device Identifier: 04048551370506
• UDI-Public: 04048551370506
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/16/2025

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: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 07/15/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/09/2025; 07/16/2025
• 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