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

Model Number	795234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the c10-3v transducer lens had a hole, resulting in exposed metal.The transducer was associated with the epiq elite diagnostic ultrasound system at the customer¿s site.The issue was discovered outside of clinical use and there was no patient or user harm associated with this event.A philips remote service engineer initiated the replacement process to resolve the customer¿s 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 damages to the c10-3v transducer lens.Based on the evidence available in this investigation, the reported damage to the lens tip most closely aligns with use related factors such as repeated handling and frequent cleaning or sterilization cycles.There is no indication of non-conforming material at shipment, nor any evidence of a design anomaly that would warrant further action.The transducer was replaced to address the customer's immediate concerns and no further similar events were reported.

• Brand Name: EPIQ ELITE DIAGNOSTIC ULTRASOUND SYSTEM
• 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: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 24264169
• Report Number: 3019216-2026-100034
• Device Sequence Number: 13269603
• Product Code: IYN
• UDI-Device Identifier: 00884838102514
• UDI-Public: (01)00884838102514
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 795234
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• 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