MAUDE Adverse Event Report: KARL STORZ IMAGING ASM,CAMERA HEAD,HX,PENDULUM,1080P

Model Number	TH111
Medical Device Problem Codes	Signal Artifact/Noise (1036); Erratic or Intermittent Display (1182)
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 camera head th111 was purchased for a urology stack.When the stack is used with lasers, clinical staff have reported interference on the monitor.The screen was flickering and had artefacts.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation: the device was not returned to the manufacturer for inspection.Therefore, no technical inspection could be carried out and the error description provided by the customer, "flickering during procedure", could not be confirmed.However, according to the reported issue, the cause can be attributed to the cameras c-mos sensor technique.Due to the rolling shutter of the camera, the high light energy of the laser unit creates artifacts in the image.This is technically not improvable yet.The above investigations did not reveal a root cause related to the labelling, the device, or its history.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,CAMERA HEAD,HX,PENDULUM,1080P
• Common Device Name: ASM,CAMERA HEAD,HX,PENDULUM,1080P
• 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
• MDR Report Key: 23770464
• Report Number: 2027009-2025-02294
• Device Sequence Number: 10615895
• Product Code: FET
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/01/2026

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: TH111
• Device Catalogue Number: TH111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 07/01/2026
• 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