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

Model Number	UI400
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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 unit has exhibited unstable pressure and flow behavior during operation, as detailed below: "the preset pressure is 12 mmhg.However, once this pressure is reached, the flow does not return to 0 as expected.Instead, low-level insufflation continues (with flow fluctuating between 1-5), which may cause the pressure to increase further to 13-15 mmhg.During this process, an abnormal valve opening and closing noise can be heard".No negative impact in state of health reported.

• 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: 24232763
• Report Number: 9610617-2026-00193
• Device Sequence Number: 16019701
• 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
• Report Date (Section B): 02/02/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/02/2026
• 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