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.

• 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
• Manufacturer Contact: joseph tamblyn ; 9900 w. innovation dr.; mail drop: rp-2130 / b4422; wauwatosa, WI
• 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

0 Patients were Involved in the Event:

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: USGETE
• Device Lot Number: 212706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage