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

Model Number	TH110
Medical Device Problem Codes	Poor Quality Image (1408); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that there was a flickering in image.No negative impact in state of health reported.
Additional Manufacturer Narrative
Correction: d3 and g1.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, "flickering in image" could be confirmed and assigned to a defective camera head cable.The th110 was found with a defective camera head cable.The reason for the defect is a break of the conductors in the camera cable by wear.The ifu nam292_en_v2.0_ifu_ce-mdr contains the following note on page 8 and 9: "3.2 correct handling and product testing if the product is not handled correctly, patients, users, and third parties may be injured.Only persons with the necessary medical qualification and who are acquainted with the application of the product may work with it.Check that the product is suitable for the procedure prior to use.Check the product for the following properties, for example, before and after every use: - functionality - damage - changes to the surface - in the case of several components: completeness and correct assembly.Do not continue to use damaged products.Dispose of the product properly." "3.8 failure of products the product may fail during use.Have a replacement product ready for each application or plan for an alternative surgical technique." the investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.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 carneros road; goleta CA
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21979064
• Report Number: 2027009-2025-00800
• Device Sequence Number: 7151926
• Product Code: FET
• UDI-Device Identifier: 04048551358924
• UDI-Public: 04048551358924
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2026

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: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 01/21/2026
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/15/2025; 02/06/2026
• 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