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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 40
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KARL STORZ SE & CO. KG ENDOFLATOR 40 Back to Search Results
Model Number UI400
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Serious Injury
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
The following was reported: "endoflator unexpectedly stopped working.Surgeon was compelled to complete the procedure through open surgery.".
 
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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
MDR Report Key25600466
Report Number2020550-2026-01442
Device Sequence Number9802549
Product Code FCX
UDI-Device Identifier04048551326640
UDI-Public04048551326640
Combination Product (Y/N)N
Initial Reporter CountryIN
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/23/2026
Report Date (Section F) 06/23/2026
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 NumberUI400
Device Catalogue NumberUI400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/19/2026
Event Location Hospital
Date Report to Manufacturer06/23/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/23/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Other;
Patient SexUnknown
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