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

Model Number	EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Stomach Ulceration (4488)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
It was reported that a patient experienced bleeding/laceration to the stomach following a transesophageal echocardiogram procedure with the s7-3t transducer and epiq 7c ultrasound system.Additional information is being obtained regarding patient outcome.The transducer has been removed from service, and the philips service engineer has initiated the replacement process to resolve the customer¿s immediate concern.Philips has started an investigation, and upon completion, a follow-up report will be submitted.
Additional Manufacturer Narrative
A qualified r&d engineer conducted a full evaluation of the returned transducer in response to the customer complaint.The device was inspected visually and by touch for any sharp edges or protrusions, and none were found.Mechanical articulation testing confirmed that the probe moved freely in all directions.The articulation mechanism operated as intended and showed no signs of bending, restriction, or conditions that would require forceful removal in a bent position.No defects of abnormalities were identified that could have contributed to the stomach injury described by the customer.The reported issue could not be confirmed.There is no evidence of a design defect, no indication of non-conforming material at the time of shipment, and no 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: 24782360
• Report Number: 3019216-2026-100131
• Device Sequence Number: 21313698
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: (01)00884838047693
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 05/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 DA
• Patient Sex: Unknown