MAUDE Adverse Event Report: Siemens Medical Solutions USA, Inc. ACUSON Origin; System, Imaging, Pulsed Doppler, Ultrasonic

Model Number	11668590
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The control panel levers on the origin system are prematurely fractured/cracked and a piece broke off.On the bottom of the handle there is a plastic piece that hangs down because it's broken off from the screw.It's very sharp and cut a sonographer on the night shift.A band-aid was applied but no medical intervention was required.
Additional Manufacturer Narrative
An investigation is ongoing at siemens healthineers to identify the root cause of the issue.The report will be supplemented after the investigation is completed.Reference# (b)(4).

• Brand Name: ACUSON Origin
• Common Device Name: System, Imaging, Pulsed Doppler, Ultrasonic
• Manufacturer (Section D): Siemens Medical Solutions USA, Inc.; 22010 se 51st st; issaquah WA 98029
• Manufacturer (Section G): Siemens Medical Solutions USA, Inc.; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 se 51st st; issaquah, WA 98029 ; +1(650)625-7209
• MDR Report Key: 50892813
• Report Number: 3023245-2026-00084
• Device Sequence Number: 10759002
• Product Code: IYN
• UDI-Device Identifier: 04056869996295
• UDI-Public: 04056869996295
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 11668590
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female