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

Model Number	TH100
Medical Device Problem Codes	Signal Artifact/Noise (1036); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image flickers over the screen and lines sometimes appear when you wiggle the camera cable.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, "there are flickers all over the screen and lines sometimes appear when you wiggle the camera cable", could be confirmed.The cause can be attributed to a defect of the camera head cable due to frequent use.The additional determined issues are independent from the reported failure from customer.According to the ifu visual as well as functionality should always be checked before every use to avoid injuries and damages to the product.Furthermore, a spare device should be available in case the device fails during use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,HEAD,IMAGE1 S,H3-Z, CE
• Common Device Name: ASM,HEAD,IMAGE1 S,H3-Z, CE
• 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
• MDR Report Key: 23089753
• Report Number: 2027009-2025-01646
• Device Sequence Number: 16073369
• Product Code: FET
• UDI-Device Identifier: 04048551333136
• UDI-Public: 04048551333136
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 04/15/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 03/31/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/28/2025; 04/15/2026
• 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