MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR

Model Number	26040EB
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/04/2025
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, the patient was admitted due to "10 days of irregular vaginal bleeding." admission diagnosis: abnormal uterine bleeding, intrauterine device in situ.On (b)(6) 2025, a hysteroscopic procedure was performed.During the procedure, an endometrial polyp was identified, and a hysteroscopic endometrial polypectomy with iud removal was planned.The surgery was performed using a storz 2 system.During the operation, a short circuit and explosion occurred at the connection point between the resectoscope loop cable and the sheath hub, accompanied by visible sparks.This resulted in a burn injury to the operator's finger, characterized by localized redness and significant pain.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: WORKING ELEMENT, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23700743
• Report Number: 2020550-2025-02233
• Device Sequence Number: 21512913
• Product Code: HIH
• UDI-Device Identifier: 04048551091784
• UDI-Public: 04048551091784
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• 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): 12/02/2025
• Report Date (Section F): 12/02/2025

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 Number: 26040EB
• Device Catalogue Number: 26040EB
• Device Lot Number: WN10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown