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

Model Number	27050D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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
It was reported that the surgeon began the coagulation process.The neutral electrode showed a green light.After just one or two attempts, the erbe vio 300 device reported an error/malfunction at the neutral electrode, even though the electrode continued to glow green.When the surgeon restarted the coagulation process, there was a violent backlash' in which the irrigation water sprayed out of the bladder and the surgeon reported receiving an electric shock.There was a burning smell in the operating theatre.The surgeon's glove was torn and there was a clear burn mark on her thumb.She complained of feeling unwell and dizzy and left the operating theatre.The operation was interrupted and the erbe vio 300 device, the resectoscope and the power cable were immediately replaced with new' devices." according to additional information received, the procedure was completed by another surgeon without any further problems.The surgeon who received the electric shock reported that she was "monitored for several hours with two ecg checks and two heart enzyme checks without dynamics.Apart from clear secretion from the wound on the right thumb, no signs of inflammation occurred in the further course.".

• Brand Name: WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 24471445
• Report Number: 2020550-2026-00284
• Device Sequence Number: 18552821
• Product Code: FDC
• UDI-Device Identifier: 04048551077474
• UDI-Public: 04048551077474
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/27/2026
• Report Date (Section F): 02/27/2026

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: 27050D
• Device Catalogue Number: 27050D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown