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

Model Number	UH801
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "on (b)(6) 2026, following normal surgical procedures, hysteroscopic endometrial lesion resection and hysteroscopic diagnostic curettage were planned for the patient.During the use of high-frequency surgical equipment, the working handpiece suddenly malfunctioned and burned the bipolar electrode cable, causing transient electric shock to the patient.The surgical equipment was suspended immediately.After replacing the spare working handpiece and electrode cable and confirming no abnormalities, the operation resumed." cross reference mdr 9610617-2026-1891, cross reference mdr 9610617-2026-1893.
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).

• 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: 50180964
• Report Number: 50180964
• Device Sequence Number: 12827786
• Product Code: GEI
• 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
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026
• Report Date (Section F): 08/07/2026

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: 07/30/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Material#: UH400.Serial#: (b)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown