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

Model Number	UI400
Medical Device Problem Codes	Defective Component (2292); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during laparoscopic-gynecological surgery, there was a subcutaneous emphysema extending up to the patient's neck.Two cases occurred on the same day in two different patients.No information about any product malfunction provided.No treatment of the subcutaneous emphysema was required.The patients are in good condition; the incident did not affect their health.2 complaint cases were created, because of the 2 patients involved.(b)(4): 1.Case, (b)(4): 2.Case.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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
Device evaluation: the product was returned on 02-sep-2025.The investigation of the product was completed on 09-dec-2025.The investigations did not reveal a root cause related to the labelling, the device, or its history.The physical investigation of the ui400 did not show any abnormality in the log files at the date of the event.However, it was determined to have a temporary mechanical defect of the low-pressure valve which may not have been triggered properly.This malfunction can support an emphysema but is not the trigger for it.No cause can be determined to the insufflator unit, ui400.The cause is determined by the patients' conditions in both cases.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: 23019517
• Report Number: 9610617-2025-01579
• Device Sequence Number: 9546787
• Product Code: FCX
• UDI-Device Identifier: 04048551326640
• UDI-Public: 04048551326640
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: UI400
• Device Catalogue Number: UI400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown