MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Working Element, bipolar

Model Number	26040EB
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the patient complained of shortness of breath, so we switched from local to general anesthesia.An ultrasound examination confirmed that the patient had developed an air embolism.We then used a stent to remove 20 cc of air from the inferior vena cava.No permanent impairment or long-term adverse outcome was reported.Cross reference mdr: 9610617-2026-01919.
Additional Manufacturer Narrative
The affected device has been requested by the manufacturer but has not yet returned for evaluation.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).Cross reference internal complaint id: (b)(4).

• 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: 50212546
• Report Number: 50212546
• Device Sequence Number: 14983149
• Product Code: HIH
• UDI-Device Identifier: 04048551091784
• UDI-Public: 04048551091784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026
• Report Date (Section F): 08/11/2026

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: 26040EB
• Device Catalogue Number: 26040EB
• Device Lot Number: SL06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2026
• 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: Other; Required Intervention
• Patient Sex: Unknown