MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; ULTRASOUND

Catalog Number	10436113
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cse inspected the probe mechanically.One-time event and unclear how it came to this.Customer doesn't want any further service activity though at present, as the probe has been working as expected since then.
Event or Problem Description
Copied from (b)(4).Customer stated that the distal tip on his z6ms locked itself in a deflected position during a procedure.Unclear how he recovered from that.When cse inspected the probe, all was working well.

• Common Device Name: ULTRASOUND
• 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 ; 6506257209
• MDR Report Key: 21750834
• Report Number: 3009498591-2025-00009
• Device Sequence Number: 8220632
• Product Code: IYN
• UDI-Device Identifier: 04056869003634
• UDI-Public: 04056869003634
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 10436113
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2024
• Initial Report FDA Received Date: 04/02/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown