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

Model Number H45581BJ

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Perforation of Esophagus (2399)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.(b)(4).Ge healthcare's investigation is on-going at this time.

Event Description

A customer complained to ge healthcare that a patient's esophagus was pierced by the 6vt-d ultrasound probe during a te exam.The physician also noted probe insertion was difficult.Initial evaluation of the 6vt-d probe indicates the probe did not malfunction.

Manufacturer Narrative

Gehc's investigation has completed.The probe was returned to gehc for analysis and the probe was evaluated.Gehc did not find any probe malfunctions.Additionally, the investigation included discussion with the customer where it was concluded there was no use error.Therefore, the conclusion gehc can draw is that the tee probe did not malfunction, and it is further concluded that the event was caused by an accidental esophagus trauma during the tee procedure, a very low, but well characterized, inherent risk of tee examinations.Gehc further evaluated the complaint file for adverse trends and none were found.No further actions are planned at this time.

• Brand Name: 6VT-D PROBE
• Type of Device: 6VT-D ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• MDR Report Key: 9578347
• MDR Text Key: 174687367
• Report Number: 9610482-2020-00001
• 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
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H45581BJ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other