MAUDE Adverse Event Report: KARL STORZ IMAGING ASM, HEAD, H1

Model Number	TH130
Medical Device Problem Codes	No Display/Image (1183); Radiofrequency Interference (RFI) (2314)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the electrosurgical unit is activated, the image on the monitor skips.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the device was returned to the manufacturer for inspection.During the technical evaluation, the customer reported issue activating the electrosurgical unit causes the image on the monitor to skip was confirmed.The root cause was identified as a random defect in the camera head cable.Specifically, the cable shielding was damaged, allowing high frequency (hf) radiation to interfere with the signal wires.As a result, the image flickers or intermittently disappears during hf treatment.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, H1
• Common Device Name: ASM, HEAD, H1
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los carneros road; goleta, ca 93117 ; GM 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los carneros road; goleta, ca 93117 ; GM 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23091981
• Report Number: 2027009-2025-01599
• Device Sequence Number: 18569556
• Product Code: GCJ
• UDI-Device Identifier: 04048551425664
• UDI-Public: 04048551425664
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K222504
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: TH130
• Device Catalogue Number: TH130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 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