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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 26775UF
Medical Device Problem Code Melted (1385)
Health Effect - Clinical Code Burn(s) (1757)
Date of Event 03/29/2024
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
 
Event or Problem Description
The incident occurred during the procedure, causing the sheath to melt and resulting in burns to the patient.
 
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Brand Name
COAGULATING AND DISSECTING ELECTRODE
Common Device Name
ELECTRODE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key19135505
Report Number2020550-2024-00111
Device Sequence Number11942169
Product Code GEI
UDI-Device Identifier04048551072417
UDI-Public4048551072417
Combination Product (Y/N)N
Initial Reporter CountryFR
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) 04/18/2024
Report Date (Section F) 04/18/2024
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 Number26775UF
Device Catalogue Number26775UF
Device Lot NumberTN05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/17/2024
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer04/18/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/18/2024
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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