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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE
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KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE Back to Search Results
Model Number 26775C
Medical Device Problem Code Mechanical Problem (1384)
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.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
Event or Problem Description
According to the information received, skin burns during surgery.As there is no more precise information about the burning degree the case is deemed reportable.
 
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Brand Name
COAGULATING AND DISSECTING ELECTRODE
Common Device Name
COAGULATING AND DISSECTING ELECTRODE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key22031684
Report Number2020550-2025-00849
Device Sequence Number12827124
Product Code GEI
UDI-Device Identifier04048551072288
UDI-Public04048551072288
Combination Product (Y/N)N
Initial Reporter CountryGM
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) 05/14/2025
Report Date (Section F) 05/14/2025
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 Number26775C
Device Catalogue Number26775C
Device Lot NumberSN04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/13/2025
Event Location Hospital
Date Report to Manufacturer05/14/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/15/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
MATERIAL: 34310MA, LOT: WM09.
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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