MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 40

Model Number	UI400
Medical Device Problem Codes	Circuit Failure (1089); Insufficient Device Problem Information (3190)
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 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 "poweron test error".No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the concerned endoflator 40 (ui400, serial (b)(6)) was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description received ("poweron test error"), could be confirmed.The error codes 3ff/325, which were shown in the log files, refer to a mismeasurement of the valve due to a leaking valve or actuator fault (leak test error or electronics error) which leads to a safe state of the unit for safety reasons.The cause of the error is determined to be an individual electronic component defect.In addition, we would like to call your attention to the following information stated in the instructions for use (endoflator 40, document: uip400_en_v2.1_10-2024_ifu_ce-mdr).Extract page 10: "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; see disposing of the product." extract page 12: "3.9 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 event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOFLATOR 40
• Common Device Name: ENDOFLATOR 40
• 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: 23058344
• Report Number: 9610617-2025-01616
• Device Sequence Number: 18334326
• Product Code: FCX
• UDI-Device Identifier: 04048551326640
• UDI-Public: 04048551326640
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K161554
• 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
• Report Date (Section B): 04/01/2026

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: UI400
• Device Catalogue Number: UI400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 04/01/2026
• 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