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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR DISSECTION ELECTRODE; BIPOLAR ELECTRODE
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KARL STORZ SE & CO. KG BIPOLAR DISSECTION ELECTRODE; BIPOLAR ELECTRODE Back to Search Results
Model Number 26159BE
Medical Device Problem Code Arcing of Electrodes (2289)
Health Effect - Clinical Code Superficial (First Degree) Burn (2685)
Date of Event 06/07/2024
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that during the surgery, an intracavitary flash occurred.The bipolar electrode was stuck inside the hysteroscope sheath.As a result, the patient had a superficial endometrial burn.
 
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
BIPOLAR DISSECTION ELECTRODE
Common Device Name
BIPOLAR ELECTRODE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key19608321
Report Number2020550-2024-00185
Device Sequence Number12370653
Product Code GCJ
UDI-Device Identifier04048551094228
UDI-Public4048551094228
Combination Product (Y/N)N
Initial Reporter CountrySP
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) 06/25/2024
Report Date (Section F) 06/25/2024
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 Number26159BE
Device Catalogue Number26159BE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/24/2024
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer06/25/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/25/2024
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: 26153BI, LOT: RL01; MATERIAL: 26176LV, LOT: XO01; MATERIAL: UH400E, SN: (B)(6)
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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