MAUDE Adverse Event Report: KARL STORZ SE & CO. KG AUTOCON III 400 HIGH-END, 100-127V

Model Number	UH400U
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).Cross reference complaint ids: (b)(4).
Event or Problem Description
It was reported that "resident was shocked using bipolar loop".Cross reference mdrs: 9610617-2025-02200.9610617-2025-02201.9610617-2025-02202.

• Brand Name: AUTOCON III 400 HIGH-END, 100-127V
• Common Device Name: AUTOCON III 400 HIGH-END, 100-127V
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 23712380
• Report Number: 2020550-2025-02199
• Device Sequence Number: 21060411
• Product Code: GEI
• UDI-Device Identifier: 04048551378809
• UDI-Public: 04048551378809
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025
• Report Date (Section F): 12/03/2025

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: UH400U
• Device Catalogue Number: UH400U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/07/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2025
• 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