MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1 S H3-Z

Model Number	TH100
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during testing with the endoscope camera system: after a period of use, the camera image became foggy, resulting in unclear view and unusable condition.The camera image was normal, but the aperture could not be adjusted, affecting intraoperative observation.The device has been taken out of service.".No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question will no be returned to manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted the event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.An incorrect address was provided in section d3, g1 and incorrect manufacture number in the initial report.This supplemental report is to provide the correct contact information for this section.Correction: mdr was previously filled was incorrect routing number, the correct routing number should have been 2027009-2026-00479, since the initial mdr was filled with 9610617-2026-00479 we will continue on using it for additional supplemental that will be created for this mdr.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: IMAGE1 S H3-Z
• Common Device Name: IMAGE1 S H3-Z
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 1 s. los cameros road; goleta, CA 93117
• MDR Report Key: 24537121
• Report Number: 9610617-2026-00479
• Device Sequence Number: 13349855
• Product Code: FET
• UDI-Device Identifier: 04048551333136
• UDI-Public: 04048551333136
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TH100
• Device Catalogue Number: TH100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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