MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ASM,CAMERA HEAD,HX,1080P

Model Number	TH110
Medical Device Problem Codes	Loose or Intermittent Connection (1371); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that in the middle of the surgery, a message appeared saying 'camera head not compatible.' the cable had a loose connection.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the device was not returned to manufacturer for investigation.An investigation of the device itself is not possible.The investigation is based on the provided information and the experience of the investigator.According to customers information, the cable nut at the camera head signal cable has come loose.Consequently, this could lead to signal interruption and therefore to a incorrect recognition of the camera head within the camera control unit.Thus, the reported error message "camera head not compatible" appears.Therefore the failure is most probable customer and handling related.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.Appropriate warnings for the correct product handling and product testing as well as how to do in case of failure are described in the corresponding instruction for use.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 SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22384389
• Report Number: 9610617-2025-01131
• Device Sequence Number: 15628321
• Product Code: FET
• UDI-Device Identifier: 04048551358924
• UDI-Public: 04048551358924
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/20/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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