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

Model Number	UH801
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported:during hysteroscopic transcervical resection of the endometrium, the patient developed convulsions when the foot pedal was pressed to activate resection.After confirming the anesthesia depth, the patient still responded when the foot pedal was pressed again, with reflex muscle contraction triggered by the pedal.The surgery was suspended, and another set of resection equipment, instruments, endoscope and electrode were replaced.A current leakage is suspected, and the patient suffered a mild electric shock.No skin burns (such as redness, blisters, eschar, etc.) were reported postoperatively, but muscle pain masked by the postoperative analgesia pump cannot be excluded.Due to the reported electric shock, this case is deemed reportable.
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).
Additional Manufacturer Narrative
Additional information: the claimed product (uh801 - bipolar high frequency cord, 400 cm) was not returned to karl storz tuttlingen for investigation.Therefore, physical technical inspection is not possible, and a clear conclusion cannot be drawn.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
• 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: 24613783
• Report Number: 9610617-2026-00577
• Device Sequence Number: 9841714
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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