MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Bipolar High Frequency Cord, 400 cm

Model Number	UH801
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: the incident involved an unexpected sparking event associated with the bipolar hf cable during an operative hysteroscopy procedure.The event resulted in minor apparent thermal effects to staff protective clothing and localized redness to the attending physician, while no patient injury was identified.Degree of burn is unknown.
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).

• 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
• MDR Report Key: 50803461
• Report Number: 2020550-2026-02184
• Device Sequence Number: 21057948
• Product Code: GEI
• UDI-Device Identifier: 04048551388778
• UDI-Public: 04048551388778
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026
• Report Date (Section F): 09/17/2026

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
• Device Lot Number: UM01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2026
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• 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
• Patient Sex: Unknown