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 may 22, 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 9610617-2026-01911, cross reference mdr 9610617-2026-01913.
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).Cross reference internal complaint id: 20260014461_201116517, cross reference internal complaint id: 20260014461_201116519.

• 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
• Manufacturer (Section G): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 50201361
• Report Number: 9610617-2026-01912
• Device Sequence Number: 13346434
• Product Code: GEI
• UDI-Device Identifier: 04048551388778
• UDI-Public: 04048551388778
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UH400AUTOCON III 400 High End, 22Serial: (b)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown