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

Model Number	EPIQ ELITE ULTRASOUND SYSTEM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their c10-3v intracavity transducer exhibited some damage to the lens tip area exposing a portion of the metal layer underneath.This probe is associated with the epiq elite ultrasound system.There was no patient or user harm.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
A failure analysis of the damaged probe face could not be performed because the transducer was not returned by the customer.As a result, the investigation is limited to the available evidence: a photograph of the damaged lens and the customer's description of the product's condition.For this particular transducer, the crescent-shaped indentations visible on the lens are consistent with the nozzle of a gel bottle being pressed or jabbed against the surface during gel application.Based on the evidence provided, the reported issue most closely aligns with customer-induced damage or misuse.There is no indication of nonconforming material at the time of shipment, nor any evidence of a design-related anomaly that would warrant further action.The manufacturer is submitting a final report at this time.If additional information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: EPIQ ELITE
• 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: 24507626
• Report Number: 3019216-2026-100078
• Device Sequence Number: 16056311
• 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
• 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): 03/12/2026

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 ELITE ULTRASOUND SYSTEM
• Device Catalogue Number: 795234
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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