FDA Adverse Event Injury Summary report: N

PHILIPS X8-2T TEE TRANSDUCER XMATRIX TEE TRANSDUCER

MDR report key: 24604684 · Received March 16, 2026

Report

Report Number
MW5185243
Event Type
Injury
Date Received
March 16, 2026
Date of Event
February 25, 2026
Report Date
March 9, 2026
Manufacturer
PHILIPS ULTRASOUND LLC
Product Code
ITX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT HAD AN OUTPATIENT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). PHYSICIAN NOTED SLIGHT RESISTANCE WITH THE PHILIPS PROBE UPON INITIAL INTUBATION. THE PROBE WAS REMOVED FROM THE AIRWAY AND PHYSICIAN NOTED PROBE TO BE CROOKED AT A 90-DEGREE ANGLE. AFTER REPOSITIONING THE PROBE, THE PROBE ADVANCED WITHOUT DIFFICULTY. THERE WAS NO EVIDENCE OF BLOOD ON THE PROBE OR ANY EVIDENCE OF PATIENT DECOMPENSATION DURING THE PROCEDURE. PATIENT SUCCESSFULLY DRANK WATER PRIOR TO DISCHARGE HOME. APPROXIMATELY 6 HOURS LATER, PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH DIFFICULTY SWALLOWING AND 10/10 PAIN. A COMPUTED TOMOGRAPHY (CT) SOFT TISSUE NECK REVEALED LIKELY ESOPHAGEAL PERFORATION THAT WAS CONFIRMED AS 3MM BY AN EMERGENT ESOPHAGOGASTRODUODENOSCOPY (EGD). PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH A NASOGASTRIC TUBE (NG), ANTIBIOTICS WERE INITIATED, AND A PICC LINE PLACED FOR TUBE FEEDING. REPEAT IMAGING FOUR DAYS LATER SHOWED NO APPRECIATED LEAK. PRIOR TO DISCHARGE HOME WITH HEALTH SERVICES 3 DAYS LATER, NG TUBE WAS REMOVED AND TUBE FEEDING WAS STOPPED. PATIENT EATING A SOFT DIET AND DRINKING WITHOUT ISSUE AND PAIN WELL CONTROLLED. THE PHILIPS TEE PROBE USED WAS A REPLACEMENT PROBE THAT WAS BROUGHT INTO THE HOSPITAL 10 DAYS PRIOR TO USE. PHYSICIAN IS CONCERNED INJURY WAS POTENTIALLY RELATED TO THE PROBE STEERING MECHANISM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
624976 PHILIPS X8-2T TEE TRANSDUCER XMATRIX TEE TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND LLC

Patients

Seq Age Sex Outcome Treatment
1 83 YR Male Required Intervention