MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1 S H3-Z FI; TH102

Model Number	TH102
Medical Device Problem Codes	Device-Device Incompatibility (2919); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the system reports incompatible camera head.The patient was already sedated and the surgery had to be canceled.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Based on the error description and the fact that the product was not returned, it can be assumed that the product is working again.Therefore, the most probable cause is that the connector of the camera head or the socket of the ccu was wet or dirty.This is described as a warning in the ifu 96206286pl, version 4.1 on page 6 to test the device prior to each surgical procedure to ensure that it functions correctly.In the event that the image becomes unusable during surgery, the camera may be disangaged from the endoscope and the procedure continued optically.If this is not possible, it is up to the discretion of the surgeon how best proceed.Availability of a spare system is recommended.Further on page 18: warning: always ensure the connector is completely clean and free of debris.If moisture is present, dry thoroughly with sterile towel prior to insertion.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: IMAGE1 S H3-Z FI
• Common Device Name: TH102
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• 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: 21103698
• Report Number: 2027009-2025-00009
• Device Sequence Number: 8636905
• Product Code: OWN
• UDI-Device Identifier: 04048551333150
• UDI-Public: 04048551333150
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152583
• 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): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TH102
• Device Catalogue Number: TH102
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (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
• Concomitant Medical Products and Therapy/Usage Dates: TC200 IMAGE1 S CONNECT.; TC300 IMAGE1 S H3-LINK.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown