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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT
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KARL STORZ SE & CO. KG WORKING ELEMENT Back to Search Results
Model Number 27050E
Medical Device Problem Code Excessive Heating (4030)
Health Effect - Clinical Code Burn(s) (1757)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
 
Event or Problem Description
It was reported that patient expressed a burning sensation during the post-surgery follow-up.Due to the burning injury this case is deemed reportable.
 
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Brand Name
WORKING ELEMENT
Common Device Name
WORKING ELEMENT
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key22322613
Report Number2020550-2025-01054
Device Sequence Number18347606
Product Code FDC
UDI-Device Identifier04048551077542
UDI-Public04048551077542
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) 06/24/2025
Report Date (Section F) 06/24/2025
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 Number27050E
Device Catalogue Number27050E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/03/2025
Event Location Hospital
Date Report to Manufacturer06/24/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/24/2025
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 Other;
Patient SexUnknown
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