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

Model Number 6VT-D

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

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.Device was manufactured pre-compliance date and therefore does not have a udi.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).Ge healthcare's investigation is ongoing at this time.

Event Description

A customer reported to ge healthcare that during a te examination, a surgical tavi procedure, the 6vt-d ultrasound probe felt like it was locked in a flexed position despite not being locked.After a while it released itself and could be pulled out.Afterwards they checked the probe visually and operationally and it was normal except there was a little blood on the probe.They reported the patient's esophagus was perforated by the 6vt-d ultrasound probe, and they have asked ge to evaluate the probe.

Manufacturer Narrative

Gehcâs investigation has completed.The probe was returned to gehc for evaluation and testing of the probe has concluded the probe has not malfunctioned mechanically.With medical review it is concluded that the root cause was an accidental esophagus injury with the inherent and well documented risks of the procedure and the patients underlying medical condition as the most likely contributing factor.No further action is being taken 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: 12268519
• MDR Text Key: 264788701
• Report Number: 9610482-2021-00005
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6VT-D
• Device Lot Number: 201285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other