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

Catalog Number	11291794
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Please send documentation that equipment is functioning properly.
Additional Manufacturer Narrative
On (b)(6) 2025 - (b)(6) - initial clarification: tse spoke with the customer (tina) and she confirmed that a customer complaint was just filed with their facility by a patient that was there on (b)(6) 2025, that claims that they was burned by the 5c1 probe during their trans-abdominal pelvic exam.The serial number of the suspect probe was not immediately available.A psi was submitted and the cse will be dispatched as requested to check out the probe and the system.

• Common Device Name: TRANSDUCER
• 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: 24801243
• Report Number: 3023245-2026-00029
• Device Sequence Number: 9944666
• Product Code: ITX
• UDI-Device Identifier: 04056869061870
• UDI-Public: 04056869061870
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 04/07/2026

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
• Device Catalogue Number: 11291794
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/07/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown