• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GE VINGMED ULTRASOUND AS 6VT-D PROBE 6VT-D ULTRASOUND TRANSDUCER Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name6VT-D PROBE
Type of Device6VT-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 Key9410996
MDR Text Key169088811
Report Number9610482-2019-00004
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K141093
Number of Events Reported1
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 Received12/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUSGETE
Device Lot Number212706
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-