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

Model Number	TH110
Medical Device Problem Codes	No Display/Image (1183); Defective Component (2292)
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 was a loose contact and image loss.No negative impact in state of health reported.There is no information that the event caused a harm or serious injury to patient, user or third party.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: during the technical inspection, the error description provided by the customer, "loose connection/image failure" could be confirmed.The most probable root cause is mechanical damage due to regular usage of the camera head.The cable is always in movement when in use, consequently a defect could occur any time.After 1814 working hours it is not unnormal that the cable breaks.The ifu is stating that the product should check for functionality, damage, change of the surface and completeness before each use.The above 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 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 ; 4242188247
• MDR Report Key: 21462361
• Report Number: 9610617-2025-00309
• Device Sequence Number: 15394582
• Product Code: FET
• UDI-Device Identifier: 04048551358924
• UDI-Public: 04048551358924
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2025

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
• Device Model Number: TH110
• Device Catalogue Number: TH110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 09/23/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/15/2025; 09/26/2025
• 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