MAUDE Adverse Event Report: KARL STORZ IMAGING ASM,HEAD,IMAGE1 S,H3-ZA, CE

Model Number	TH104
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device will not be returned for investigation to the manufacturer.Should additional information / investigation results become available, a supplemental report will be submitted.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that camera head is defective out of the box and flickered during first case used.No negative impact in state of health reported.

• Brand Name: ASM,HEAD,IMAGE1 S,H3-ZA, CE
• Common Device Name: ASM,HEAD,IMAGE1 S,H3-ZA, CE
• 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: 24968250
• Report Number: 2027009-2026-00905
• Device Sequence Number: 17391432
• Product Code: FET
• UDI-Device Identifier: 04048551333969
• UDI-Public: 04048551333969
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/23/2026

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: TH104
• Device Catalogue Number: TH104
• 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: 04/09/2026
• Initial Report FDA Received Date: 04/23/2026
• 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