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

Model Number	795231
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that when the x8-2t transducer was removed from a patient during a transesophageal exam, the tip was still in the bent position and the patient was possibly harmed during this procedure.The transducer was associated with the epiq cvx ultrasound system.Additional information is being obtained to determine patient outcome.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Event or Problem Description
This is supplemental report only, ref: medwatch mw5185243.This event has already been reported to fda, ref: mfr report number 3019216-2026-100114.
Additional Manufacturer Narrative
This is supplemental report only, ref: medwatch mw5185243.This event has already been reported to fda, ref: mfr report number 3019216-2026-100114.
Additional Manufacturer Narrative
A field service engineer evaluated the x8-2t transducer in response to the customer's complaint.The engineer tested the articulation mechanism and steering knob functionality, confirming that the transducer was fully capable of articulating in all directions and was not stuck in a bent position.When articulated through its full range of motion, the transducer could also be returned to the neutral position without any resistance.No faults or operational issues were identified with the articulation mechanism, and all functional issues passed.Because the customer declined to return the transducer, no additional investigation could be performed.The system has since been returned to service, and no similar issues have been reported.No further details about the patient's clinical outcome could be obtained.

• Brand Name: EPIQ 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: 24708786
• Report Number: 3019216-2026-100114
• Device Sequence Number: 16069073
• Product Code: IYN
• UDI-Device Identifier: 00884838123960
• UDI-Public: (01)00884838123960
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 795231
• Device Catalogue Number: 795231
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 05/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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: Other
• Patient Sex: Unknown