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

Model Number KN100120

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

Patient Problem Perforation of Esophagus (2399)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Outcome for the patient was reported to ge healthcare (gehc) from the customer, where the customer said the patient has been discharged in good condition.Gehcare's investigation has completed.The probe was returned to gehc for analysis.Gehc evaluated the probe and did not find any probe malfunctions.Therefore, the conclusion gehc can draw is that the tee probe did not malfunction, and given the limited information provided by the customer it is inconclusive that the probe caused the adverse event.Without a probe malfunction it is further concluded that the event was caused by an accidental esophagus lesion during the tee procedure, where the potential root causes might be the patient suffering from very weak esophagus walls, and/or the operator misinterpreted the feedback of the tee probe insertion.Gehc further evaluated the complaint file for adverse trends and none were found.No further actions are planned at this time.

Event Description

The customer initially reported to ge healthcare that a patient suffered an injury to the aorta during a tee exam while using the 6vt-d ultrasound probe.Ge healthcare contacted the customer to obtain additional information at which time the customer said the injury was to the esophagus and there was no injury to the aorta.

• 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
• Manufacturer Contact: joseph tamblyn ; 9900 w. innovation dr.; mail drop: rp-2130 / b4422; wauwatosa, WI
• MDR Report Key: 9418234
• MDR Text Key: 169297949
• Report Number: 9610482-2019-00005
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KN100120
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2018
• 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): Other