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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DISSECTING ELECTRODE
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KARL STORZ SE & CO. KG DISSECTING ELECTRODE Back to Search Results
Model Number 26870UFS
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/06/2025
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It is unknown if the affected device will be returned for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
 
Event or Problem Description
The item was used on a surgery karl storz 26870ufs: monopolar dissect l shaped electrode short, resulting in a patient injury.
 
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Brand Name
DISSECTING ELECTRODE
Common Device Name
DISSECTING ELECTRODE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, deu 78532 ,
GM  78532,
MDR Report Key22331329
Report Number2020550-2025-01094
Device Sequence Number18537426
Product Code GEI
UDI-Device Identifier04048551072578
UDI-Public04048551072578
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
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) 06/25/2025
Report Date (Section F) 06/25/2025
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 Number26870UFS
Device Catalogue Number26870UFS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/09/2025
Event Location Hospital
Date Report to Manufacturer06/25/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/25/2025
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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