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

Model Number	TH110
Medical Device Problem Codes	Break (1069); Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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).
Event or Problem Description
It was reported that there is intermittent image transmission.There is no information if this happened during surgery.There is no information that the event caused a harm or serious injury to patient, user or third party.
Additional Manufacturer Narrative
Date of investigation: 2026-01-14.Result of investigation: the repair technician was able to verify the customer's failure description "intermittent image transmission evident" by inspecting the device.During the incoming inspection, the customer's complaint was attributed to the broken camera cable.The fault can therefore be clearly confirmed.The grasping mechanism is slightly worn.The th110 was determined to a defective shielding of the camera head cable which consequently could be influenced by hf radiation.The broken shielding is caused by wear by using the cable.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,CAMERA HEAD,HX,1080P
• Common Device Name: ASM,CAMERA HEAD,HX,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, CA 90245
• MDR Report Key: 22895815
• Report Number: 9610617-2025-01472
• Device Sequence Number: 20312481
• Product Code: FET
• UDI-Device Identifier: 04048551358924
• UDI-Public: 04048551358924
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K160044
• 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): 02/09/2026

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: TH110
• Device Catalogue Number: TH110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 02/09/2026
• 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