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

Model Number	UI400
Medical Device Problem Codes	Improper Flow or Infusion (2954); 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.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the flow compensation is not working.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
The device in question (ui400, endoflator 40, sn: (b)(6), manufactured 30-may-2025) was received by the manufacturing site in germany on 16-dec-2025 for investigation.During the manufacturer's technical inspection, the error description provided by the customer, "flow compensation is not working", could not be confirmed.Since no faults or irregularities could be found inside the device, the cause can be attributed to incorrect use by the user.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.Internal karl storz reference number: (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: 23661057
• Report Number: 9610617-2025-02175
• Device Sequence Number: 9072172
• Product Code: FCX
• UDI-Device Identifier: 04048551326640
• UDI-Public: 04048551326640
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/02/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 05/11/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/12/2026; 06/02/2026
• 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