MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 6VT-D PROBE W/VIVID S70; TRANSESOPHAGEAL ULTRASOUND PROBE

Model Number KN100120/VIVID S70

Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189)

Patient Problems Dysphagia/ Odynophagia (1815); Injury (2348); Skin Inflammation (2443)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.

Event Description

Customer in (b)(6) reported an injury to the patient, significant dysphagia post intraoperative surgery for mitral-clip placement, due to the use of a 6vt-d te probe with a vivid s70.Subsequently the physician proceeded to use a ct scan + gastrofibroscopy in emergency to evaluate the patient.They diagnosed a severe inflammation of the basal part of the esophagus.

Manufacturer Narrative

Ge's investigation of the event has completed.The device did not malfunction and it is operating as designed.

• Brand Name: 6VT-D PROBE W/VIVID S70
• Type of Device: TRANSESOPHAGEAL ULTRASOUND PROBE
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten ; NO
• Manufacturer Contact: joseph tamblyn ; 9900 w. innovation dr.; mail drop: rp-2138; wauwatosa, WI
• MDR Report Key: 6371615
• MDR Text Key: 68770498
• Report Number: 9610482-2017-00003
• 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: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: KN100120/VIVID S70
• Other Device ID Number: SEE BLOCK H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention