MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EPIQ 7; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 7 ULTRASOUND
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported the 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 7g ultrasound system.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
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 clearly 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.

• Brand Name: EPIQ 7
• 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: 24839952
• Report Number: 3019216-2026-100142
• Device Sequence Number: 9631044
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: (01)00884838047693
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K132304
• 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): 05/18/2026

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
• Device Model Number: EPIQ 7 ULTRASOUND
• Device Catalogue Number: 795200
• 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: 03/28/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2017
• 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