MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ ELITE; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ ELITE ULTRASOUND SYSTEM
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intracavity 3d9-3v probe was leaking oil from tip.The probe was associated with the epiq elite ultrasound system at the customer¿s site.The issue was discovered outside of clinical use and no patient or user was harmed as a result of the issue.The customer was provided with a replacement transducer to address their immediate concerns.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed to determine the cause of the reported problem.A qualified field service engineer evaluated the 3d9-3v transducer based on the customer complaint.The field service engineer discovered oil on the outside of the probe.The customer's complaint was addressed by replacing the transducer.The 3d9-3v returned for further failure analysis.The investigation confirmed the transducer was damaged with a hole in the dome which allowed for oil to leak out.Additionally, the probe failed electrical tests and imaging tests due to air in dome from oil loss.No further similar issues have been reported by the customer post repair.

• Brand Name: EPIQ ELITE
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 22903897
• Report Number: 3019216-2025-000298
• Device Sequence Number: 20816412
• Product Code: IYN
• UDI-Device Identifier: 00884838102514
• UDI-Public: (01)00884838102514
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: EPIQ ELITE ULTRASOUND SYSTEM
• Device Catalogue Number: 795234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown