MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR HIGH FREQUENCY CORD, 400 CM

Model Number	UH801
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: at 9:30 a.M.On (b)(6) 2026, during surgical tissue resection on a patient, the electrosurgical cutting wire suddenly short-circuited and burned out, resulting in a burn on the patient's skin surface.According to the provided information, a treatment of the burn was required.Due to the reported burn on the patent's skin, this case is deemed reportable.

• Brand Name: BIPOLAR HIGH FREQUENCY CORD, 400 CM
• Common Device Name: BIPOLAR HIGH FREQUENCY CORD, 400 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 25036843
• Report Number: 2020550-2026-00976
• Device Sequence Number: 9039472
• Product Code: FET
• UDI-Device Identifier: 04048551388778
• UDI-Public: 04048551388778
• 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): 04/29/2026
• Report Date (Section F): 04/29/2026

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: UH801
• Device Catalogue Number: UH801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• 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