MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EPIQ 5; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 5 ULTRASOUND
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intracavity model 3d9-3v probe was leaking oil from the lens area.The probe was associated with the epiq 5g 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's complaint was addressed by providing information for a replacement transducer.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
The complaint was escalated for a product analysis; however, the customer declined service and chose not to replace the 3d9-3v transducer.As such, the transducer could not be obtained for failure analysis.Based on the evidence available in this investigation, the reported leaking of fluid from the dome may have been a result of use-related factors such as repeated handling or gouge/impact damage sustained by the dome.There is no indication of non-conforming material at shipment, nor any evidence of a design anomaly that would warrant further action.

• Brand Name: EPIQ 5
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 24792899
• Report Number: 3019216-2026-100136
• Device Sequence Number: 13236800
• Product Code: IYN
• UDI-Device Identifier: 00884838047686
• UDI-Public: (01)00884838047686
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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 5 ULTRASOUND
• Device Catalogue Number: 795204
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 09/18/2019
• 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