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

Model Number	UH801
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6)2026, according to the standard surgical procedure, the patient was scheduled to undergo hysteroscopic endometrial lesion resection + hysteroscopic cervical lesion resection + fractional diagnostic curettage + cervical biopsy.During the operation, while using the high-frequency electrosurgical device, the working handpiece suddenly burned through the bipolar electrode cable, causing the patient to experience a brief electric shock.The use of the device was immediately discontinued, and a backup working handpiece and electrode cable were replaced.After confirming no issues, the surgery continued.New additional information was received on july 24, 2026.Based on the new information there are 3 additional potentially causal karl storz products involved in the event and additional reported error description: "the sealing ring leaks, and water flows through the gap to the electrode cable during the procedure." cross reference mdr: 9610617-2026-01599, 9610617-2026-01797, 9610617-2026-01799.
Additional Manufacturer Narrative
Under user's discretion the device in question will not be returned to the manufacturer for evaluation.The investigation will be performed by a designated karl storz employee, investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).Cross reference internal 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
• 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 ; +1(424)218-8247
• MDR Report Key: 50122174
• Report Number: 9610617-2026-01798
• Device Sequence Number: 21472928
• 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): 08/03/2026

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: Unknown
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/03/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown