MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 6VT-D PROBE; 6VT-D ULTRASOUND TRANSDUCER

Model Number USGETE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Perforation of Esophagus (2399)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ge healthcare's investigation is on-going at this time.

Event Description

A customer reported to ge healthcare that during a te exam the patient's esophagus was pierced by the 6vt-d ultrasound probe.

Manufacturer Narrative

On february 25, 2020, the customer provided additional information to gehc.The following is the additional information.The patient was a difficult intubation and the doctor proceeded with the exam and completed it.Within the day the patient ran into trouble, and when they investigated they found air in the mediastinum.Further investigations revealed that there was a perforation (puncture) at the lower level of the esophagus near the stomach after transgastic views.They did not know about the esophagus perforation until after the exam.The patient died in the later part of december 2019.Gehc's investigation conclusion as filed in supplement 1 remains the same, and no further action will be taken.

Manufacturer Narrative

Gehc's investigation has completed.Based on the functional and safety inspection of the probe used during the exam, no probe malfunction or other safety concern was identified.It was therefore concluded that the root cause of the event was caused by an accidental esophagus trauma during the transesophageal echocardiography procedure.It was discovered after the fact that the patient was suffering from esophageal disorder that would normally have disqualified a tee procedure.Injury under such circumstances is a well characterized, inherent risk of tee examinations.There is no evidence of a malfunction that occurred as a result of the design, production, or manufacturing process for this product.No further action will be taken.

• Brand Name: 6VT-D PROBE
• Type of Device: 6VT-D ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-318 3; NO N-3183
• MDR Report Key: 9410996
• MDR Text Key: 169088811
• Report Number: 9610482-2019-00004
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K141093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2020

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
• Device Operator: Health Professional
• Device Model Number: USGETE
• Device Lot Number: 212706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 11/22/2019; 11/22/2019
• Supplement Dates FDA Received: 01/20/2020; 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1